198 Jobs für Clinical Regulatory Affairs Manager
Stellenangebote Clinical Regulatory Affairs Manager Jobs
Job vor 3 Tagen bei Stellen-Online gefunden
PARI Pharma GmbH
• 82319, Starnberg
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] deren Angehörige dabei, ihr Leben zu erleichtern. Werden Sie Teil unserer Mission und gestalten Sie mit uns die Zukunft Bringen Sie Ihre Expertise am Standort Starnberg mit [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] ein als Medical Affairs Manager (m/w/d) in Vollzeit (Schwerpunkt: Klinische Bewertung Medizinprodukte) Als Medical Affairs Manager (m/w/d) übernehmen Sie eine zentrale Rolle bei der medizinisch-wissenschaftlichen Bewertung und Begleitung unserer Medizinprodukte insbesondere solcher, mit denen Arzneimittel vernebelt werden. Sie gestalten klinische Bewertungen eigenverantwortlich und stellen deren regulatorische Konformität über den gesamten Produktlebenszyklus sicher. Ihre Aufgaben im Überblick:Eigenverantwortliche Erstellung, Pflege und Aktualisierung von Clinical Evaluation Reports (CERs) gemäß MDR Erarbeitung von Clinical Evaluation Plans (CEP) sowie Post-Market Clinical Follow-up (PMCF) Plänen und Reports Bewertung und Zusammenfassung klinischer Daten aus Studien, Literatur und Post-Market-Daten Medizinisch-wissenschaftliche Unterstützung interner Stakeholder, insbesondere aus Forschung Entwicklung, Quality Management, Produktmanagement sowie Marketing Enge Mitarbeit in [. .. ] Guidelines und gesundheitspolitischer Entwicklungen Fachlicher Austausch mit externen Dienstleistern, ggf. Prüfstellen und weiteren Partnern Ihr Profil:Abgeschlossenes Studium der Medizin, Pharmazie oder Naturwissenschaften idealerweise ergänzt durch einen Master of Drug and Regulatory Affairs Mehrjährige praktische Erfahrung in der Erstellung klinischer Bewertungen für Medizinprodukte, bevorzugt im Umfeld von inhalativen/ respiratorischen Systemen Sehr gute Kenntnisse der MDR sowie der regulatorischen Anforderungen an CERs Erfahrung aus einem Dienstleistungsumfeld (z. B. Consulting, CRO, Regulatory Service Provider) von Vorteil Routine im Arbeiten in komplexen Projektstrukturen Erfahrung in [. .. ]
Job am 16.01.2026 bei Mindmatch.ai gefunden
PARI Pharma GmbH
Medical Affairs Manager (m/w/d)
• Starnberg, BY
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] deren Angehörige dabei, ihr Leben zu erleichtern. Werden Sie Teil unserer Mission und gestalten Sie mit uns die Zukunft Bringen Sie Ihre Expertise am Standort Starnberg mit [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] ein als Medical Affairs Manager (m/w/d) in Vollzeit (Schwerpunkt: Klinische Bewertung Medizinprodukte) Als Medical Affairs Manager (m/w/d) übernehmen Sie eine zentrale Rolle bei der medizinisch-wissenschaftlichen Bewertung und Begleitung unserer Medizinprodukte insbesondere solcher, mit denen Arzneimittel vernebelt werden. Sie gestalten klinische Bewertungen eigenverantwortlich und stellen deren regulatorische Konformität über den gesamten Produktlebenszyklus sicher. Ihre Aufgaben im Überblick Eigenverantwortliche Erstellung, Pflege und Aktualisierung von Clinical Evaluation Reports (CERs) gemäß MDR Erarbeitung von Clinical Evaluation Plans (CEP) sowie Post-Market Clinical Follow-up (PMCF) Plänen und Reports Bewertung und Zusammenfassung klinischer Daten aus Studien, Literatur und Post-Market-Daten Medizinisch-wissenschaftliche Unterstützung interner Stakeholder, insbesondere aus Forschung Entwicklung, Quality Management, Produktmanagement sowie Marketing Enge Mitarbeit in [. .. ] und gesundheitspolitischer Entwicklungen Fachlicher Austausch mit externen Dienstleistern, ggf. Prüfstellen und weiteren Partnern Ihr Profil Abgeschlossenes Studium der Medizin, Pharmazie oder Naturwissenschaften idealerweise ergänzt durch einen Master of Drug and Regulatory Affairs Mehrjährige praktische Erfahrung in der Erstellung klinischer Bewertungen für Medizinprodukte, bevorzugt im Umfeld von inhalativen/ respiratorischen Systemen Sehr gute Kenntnisse der MDR sowie der regulatorischen Anforderungen an CERs Erfahrung aus einem Dienstleistungsumfeld (z. B. Consulting, CRO, Regulatory Service Provider) von Vorteil Routine im Arbeiten in komplexen Projektstrukturen Erfahrung in [. .. ]
Job am 17.01.2026 bei jobanzeigen.de gefunden
PARI Pharma GmbH
• starnberg, Deutschland
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] deren Angehörige dabei, ihr Leben zu erleichtern. Werden Sie Teil unserer Mission und gestalten Sie mit uns die Zukunft Bringen Sie Ihre Expertise am Standort Starnberg mit [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] ein als Medical Affairs Manager (m/w/d) in Vollzeit (Schwerpunkt: Klinische Bewertung Medizinprodukte) Als Medical Affairs Manager (m/w/d) übernehmen Sie eine zentrale Rolle bei der medizinisch-wissenschaftlichen Bewertung und Begleitung unserer Medizinprodukte insbesondere solcher, mit denen Arzneimittel vernebelt werden. Sie gestalten klinische Bewertungen eigenverantwortlich und stellen deren regulatorische Konformität über den gesamten Produktlebenszyklus sicher. Ihre Aufgaben im Überblick: Eigenverantwortliche Erstellung, Pflege und Aktualisierung von Clinical Evaluation Reports (CERs) gemäß MDR Erarbeitung von Clinical Evaluation Plans (CEP) sowie Post-Market Clinical Follow-up (PMCF) Plänen und Reports Bewertung und Zusammenfassung klinischer Daten aus Studien, Literatur und Post-Market-Daten Medizinisch-wissenschaftliche Unterstützung interner Stakeholder, insbesondere aus Forschung Entwicklung, Quality Management, Produktmanagement sowie Marketing Enge Mitarbeit in [. .. ] und gesundheitspolitischer Entwicklungen Fachlicher Austausch mit externen Dienstleistern, ggf. Prüfstellen und weiteren Partnern Ihr Profil: Abgeschlossenes Studium der Medizin, Pharmazie oder Naturwissenschaften idealerweise ergänzt durch einen Master of Drug and Regulatory Affairs Mehrjährige praktische Erfahrung in der Erstellung klinischer Bewertungen für Medizinprodukte, bevorzugt im Umfeld von inhalativen/ respiratorischen Systemen Sehr gute Kenntnisse der MDR sowie der regulatorischen Anforderungen an CERs Erfahrung aus einem Dienstleistungsumfeld (z. B. Consulting, CRO, Regulatory Service Provider) von Vorteil Routine im Arbeiten in komplexen Projektstrukturen Erfahrung in [. .. ]
Job am 17.01.2026 bei Jobware gefunden
MED- EL Medical Electronics
Clinical Evaluations Manager (m/f/d)
• Innsbruck (Österreich)
Clinical Evaluations
Manager (m/f/d) Research Development Innsbruck, Austria Professionals Full-Time 38.5h Permanent Apply Now Your Tasks Planning, coordination, and management of clinical evaluation activities while ensuring compliance with
regulatory requirements [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and internal quality standards Research, compilation, and analysis of clinical data from studies, tests, scientific literature, and post-market experience Preparation, review, and verification of clinical evaluation reports and related documentation to assess the safety and performance of MED-EL products in accordance with applicable regulations Continuous development and [. .. ] external partners Your Profile Masters degree or higher degree (University, FH) in Life Sciences, Natural Sciences, Healthcare, Medicine, Engineering or Technical Sciences Proven experience in scientific writing Experience with Regulatory Affairs is a plus Excellent communication skills in English, both written and spoken; German skills are desirable Understanding of, and enthusiasm for scientific working, medical technology, and clinical research Your Benefits Central Location Employee Events Flexible Hours International Environment Onboarding Workplace Well-Being Central Location Employee Events Flexible Hours International Environment [. .. ]
Job vor 3 Tagen bei Jooble gefunden
Stryker
• Regierungsbezirk Freiburg
Beratungs-/ Consultingtätigkeiten
Senior
Clinical Affairs Specialist (m/f/d) We are seeking a Senior Clinical Affairs Specialist to support Strykers Instruments Division. The role will support the Craniomaxillofacial (CMF) business unit which has a [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] well-earned reputation as a market leader for innovative developments providing instrumentation and implantable medical devices in cranial, maxillofacial and sternal [. .. ] procedures. In this role at our Freiburg site, you will lead the planning, creation, and maintenance of Clinical Evaluation documents. As the lead technical expert, you will apply your scientific, regulatory, and project management expertise to compile and assess the Clinical Evidence that underpins conclusions on product safety and performance throughout the entire lifecycle. You will work closely with the Medical Expert to reach sound scientific decisions. You will apply your scientific, regulatory and project management skills to compile the body [. .. ] and analyze the current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques Serve as the Clinical Evaluation Project Manager, supporting the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle, and fostering alignment with adjacent complex processes (Marketing strategy and claims, regulatory strategy, clinical research strategy, testing strategy) . Develop, define and defend appropriate clinical strategies to support international regulatory approvals. Contribute throughout the full [. .. ]
Job vor 3 Tagen bei Jooble gefunden
Stryker
Clinical Affairs Specialist (m/f/d)
• Regierungsbezirk Freiburg
Senior
Clinical Affairs Specialist (m/f/d) We are seeking a Senior Clinical Affairs Specialist to support Strykers Instruments Division. The role will support the Craniomaxillofacial (CMF) business unit which has a [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] well-earned reputation as a market leader for innovative developments providing instrumentation and implantable medical devices in cranial, maxillofacial and sternal [. .. ] world. In this role at our Freiburg site, you will lead the planning, creation, and maintenance of Clinical Evaluation documents. As the lead technical expert, you will apply your scientific, regulatory, and project management expertise to compile and assess the Clinical Evidence that underpins conclusions on product safety and performance throughout the entire lifecycle. You will work closely with the Medical Expert to reach sound scientific decisions. In this role at our Freiburg site, you will play the lead role in [. .. ] and analyze the current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques Serve as the Clinical Evaluation Project Manager, supporting the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle, and fostering alignment with adjacent complex processes (Marketing strategy and claims, regulatory strategy, clinical research strategy, testing strategy) . Develop, define and defend appropriate clinical strategies to support international regulatory approvals. Contribute throughout the full [. .. ]
Job vor 3 Tagen bei Jooble gefunden
Stryker
• Regierungsbezirk Freiburg
Beratungs-/ Consultingtätigkeiten
Senior
Clinical Affairs Specialist (m/f/d) We are seeking a Senior Clinical Affairs Specialist to support Strykers Instruments Division. The role will support the Craniomaxillofacial (CMF) business unit which has a [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] well-earned reputation as a market leader for innovative developments providing instrumentation and implantable medical devices in cranial, maxillofacial and sternal [. .. ] procedures. In this role at our Freiburg site, you will lead the planning, creation, and maintenance of Clinical Evaluation documents. As the lead technical expert, you will apply your scientific, regulatory, and project management expertise to compile and assess the Clinical Evidence that underpins conclusions on product safety and performance throughout the entire lifecycle. You will work closely with the Medical Expert to reach sound scientific decisions. You will apply your scientific, regulatory and project management skills to compile the body [. .. ] and analyze the current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques Serve as the Clinical Evaluation Project Manager, supporting the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle, and fostering alignment with adjacent complex processes (Marketing strategy and claims, regulatory strategy, clinical research strategy, testing strategy) . Develop, define and defend appropriate clinical strategies to support international regulatory approvals. Contribute throughout the full [. .. ]
Job vor 4 Tagen bei Jooble gefunden
Sr CRA in oncology-Sponsor dedicated-Home Based Germany
• München
Sr CRA in oncology-Sponsor dedicated-Home Based Germany Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique
clinical, medical
affairs and commercial [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, [. .. ] create a place where everyone feels like they belong. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/ escalates serious issues to the project team and develops action plans. Maintains a working knowledge of [. .. ] training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings. Qualifications: Bachelors degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ ICH Guidelines and other applicable regulatory requirements Preferably oncology experience Must demonstrate good computer skills and [. .. ]
Job vor 4 Tagen bei Jooble gefunden
Abb Vie
• Ludwigshafen am Rhein
Führungs-/ Leitungspositionen
Work-Life-Balance
[. .. ] (Product Development Strategy Team leader) for all Drug Product Development topics and will work closely with cross-functional subject matter experts from Discovery, analytical, and device development, Quality [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Assurance, CMC Regulatory Affairs, parental Product Development Science Technology (Operations) and external partners You represent Biologics Drug Product Development Germany as single point of contact in global Product Development Strategy Teams and are responsible for the formulation, manufacturing process and container closure system development of early-stage biological assets up to clinical phase III. You represent Biologics Drug Product Development Germany in project specific early-stage Development Sciences Core Teams connecting discovery with toxicology, DMPK and drug substance and drug product. You translate expert knowledge and project specifics into efficient and patient centric Drug Product development strategies. For this you establish, align, [. .. ]
Job vor 4 Tagen bei Jooble gefunden
Abb Vie
Product Manager (m/w/d) - Full time
• Ludwigshafen am Rhein
Work-Life-Balance
[. .. ] (Product Development Strategy Team leader) for all Drug Product Development topics and will work closely with cross-functional subject matter experts from Discovery, analytical, and device development, Quality [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Assurance, CMC Regulatory Affairs, parental Product Development Science Technology (Operations) and external partners You represent Biologics Drug Product Development Germany as single point of contact in global Product Development Strategy Teams and are responsible for the formulation, manufacturing process and container closure system development of early-stage biological assets up to clinical phase III. You represent Biologics Drug Product Development Germany in project specific early-stage Development Sciences Core Teams connecting discovery with toxicology, DMPK and drug substance and drug product. You translate expert knowledge and project specifics into efficient and patient centric Drug Product development strategies. For this you establish, align, [. .. ]
Job vor 4 Tagen bei Jooble gefunden
Abb Vie
• Ludwigshafen am Rhein
Work-Life-Balance
[. .. ] (Product Development Strategy Team leader) for all Drug Product Development topics and will work closely with cross-functional subject matter experts from Discovery, analytical, and device development, Quality [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Assurance, CMC Regulatory Affairs, parental Product Development Science Technology (Operations) and external partners You represent Biologics Drug Product Development Germany as single point of contact in global Product Development Strategy Teams and are responsible for the formulation, manufacturing process and container closure system development of early-stage biological assets up to clinical phase III. You represent Biologics Drug Product Development Germany in project specific early-stage Development Sciences Core Teams connecting discovery with toxicology, DMPK and drug substance and drug product. You translate expert knowledge and project specifics into efficient and patient centric Drug Product development strategies. For this you establish, align, [. .. ]
Job vor 10 Tagen bei Jooble gefunden
Stryker
Associate Manager, Clinical Data Sciences
• Regierungsbezirk Freiburg
Grow Your Career at Stryker as an Associate
Manager,
Clinical Data Science As an Associate Manager for Clinical Data Sciences, you will lead a diverse team of experts [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and collaborate with internal and external stakeholders to implement and execute Clinical Data Sciences initiatives for the Instruments division. This role involves driving operational planning, building technical infrastructure to support excellence in [. .. ] and manage the Clinical Data Sciences team, which will leverage data from various sources to foster clinical evidence communication to regulators, global health funding authorities, payers, and customers and enable regulatory approvals/ clearance, market access, and sustained product availability across the product lifecycle. Drive operational excellence by developing and maintaining technical infrastructure, platforms, and automation solutions to support effective evidence communication and efficiency. Drive innovation through data analytics, predictive modeling, and AI applications. Provide strategic insight into evidence requirements for global launch strategies, identify gaps, and define goals for Clinical Data Sciences initiatives in collaboration with Clinical Research, Medical Affairs, Regulatory, Reimbursement Market Access, Marketing, and R D teams. Build and maintain clinical databases and data management systems to ensure effective and efficient availability of evidence for regulatory, market access, and marketing needs. Learn and leverage advanced analytics techniques, including machine learning and artificial intelligence, to interpret complex clinical datasets [. .. ]
Job vor 10 Tagen bei Jooble gefunden
Abb Vie
• Wiesbaden
[. .. ] information about Abb Vie, please visit us at. Follow abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok. Job Description The HTA Writer is [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] responsible for providing clinical EUHTA document support to the JCA core team, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the clinical writing process. Provides HTA writing expertise for multiple compounds and/or projects, expertise in HTA, oncology is a plus within a therapeutic area. Interfaces with JCA core and extended teams (e. g. , HTA Strategy, Access, DSS HTA Stats, VAC, HEOR Strategy, Medical Affairs, Regulatory, Safety) to ensure accurate and timely completion/ delivery of information and review of EUHTA submissions. Responsibilities: Able to write less complex document types (unmet need, disease burden sections) , with little supervision. Requires close supervision/ mentoring on more complex document type and relies on review of subject matter experts and [. .. ] per EU HTA regulations and guidance materials. Arranges and conducts review meetings with the team. Acts as interface to resolve issues and questions arising during the writing process. Works with manager throughout the document audit process and works with JCA Core team and manager to draft responses as necessary. Produces and maintains focusing on quality and compliance and ensures delivery within project timelines. Familiarity with HTA dossier regulations, requirements and guidance associated with EU HTA regulations. Qualifications A minimum of 3+ [. .. ]
Job am 23.01.2026 bei Jooble gefunden
Clinical Trial Lead-single client-Austria, Germany or the UK
• München
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique
clinical, medical
affairs and commercial insights into outcomes to address modern [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, [. .. ] training; We are continuously building the company we all want to work for and our customers want to work with. Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOPs, and regulatory requirements. Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customers and the Companys contractual agreement. Lead project team to ensure quality, timelines and budget management. Accountable for the financial performance of each project. Coordinate activities and [. .. ]
Job am 18.01.2026 bei Jooble gefunden
Gilead Sciences
• München
[. .. ] in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Job Description Sr Manager Market Access (m/f/d) Biotstatistics/ Epidemiology-Cell Therapy Oncology Company Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living [. .. ] and supporting preparations for the AMNOG process (early advice meetings, value dossier preparation, oral hearings ) Conducting pricing exercises, contributing to price negotiations with GKV-SV Providing input in to clinical development to ensure optimal reimbursement and launch readiness for the respective product. Advice on biostatistical needs, with a focus on AMNOG Ensuring pricing analysis and modelling, support of price databases Design, conduction and publication of HEOR studies, including RWD Collaboration with local Market Access, Medical, Regulatory, Government and Public Affairs colleagues, Global HEOR and Value Access colleagues. Knowledge, Experience and Skills Masters degree in Biostatistics and profound knowledge in Market Access 3+ years of experience in Biotech, Pharma or healthcare organizations with a focus on Market Access Excellent understanding and application of statistical methods defined by G-BA and IQWi G [. .. ]
Job am 16.01.2026 bei Jooble gefunden
Abb Vie
Joint Clinical Assessment (JCA) Dossier Manager, International HTA Strategy
• Wiesbaden
[. .. ] to innovative treatments by harmonizing methodologies, establishingpredictabilityand avoiding duplications. For Abb Vie, thisprovidesa unique opportunity todemonstratethe value attributes of our assets strengthen affiliate position in country P [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] R appraisals. Joint Clinical Assessments is the keycomponentof the EU HTA regulation andcomprisesthe EU HTA dossier that will need to besubmittedto the Member State Coordination Group on HTA; eg, to address issues of relative effectiveness and relative safety within a single submission. For Abb Vie, JCA will enable better planning of market access strategies [. .. ] the successful launch of Abbvie assets. The International HTA Strategy teamoversees EU HTA Regulation implementation for Abb Vie and leads JSC and JCA strategy development and execution. Purpose Asa JCA Dossier Manager, you will leadend-to-end JC Adossierprocess supporting the strategy development and execution of JC Adossier. You willprovideexpertisein EUHT Aregulationsensuring that all requirementsare met. Serves as an EU HT Adossierexpert for the JCA dossier team. You will ensure the JCA cross-functional teams successfully deliverhigh quality executionof all JCA procedural stepswithin scope, on time, and within budget. You will ensure that projectobjectivesare achieved while adhering to quality and regulatory standards. You will serve as a liaison to HTA external authorities. You will serve as the JCA dossierexpertfor all Therapeutics Areasandall European countries. As EU HTA introduces new requirements and expectations, you will help shape internal operational processes, embed learnings, and build organizational capability in this evolving environment. Keyresponsibilities: Lead the [. .. ] meet timelines and conduct activities effectively. Acts as advisor to the JCA core team and coordinate JCA dossier cross-functional teams, including Access Lead, HEOR Strategy, DSS Stats, VAC, Medical Affairs, Regulatory teams and Access affiliates. Oversee evidence retrieval activities and ensure outputs are integrated into the dossier with the HTA writers. Ensure adherence to regulation requirements and quality standards specific to the EUHTA regulation and guidance Responsible for the liaison with external European HTA authorities. Identify key risks early, propose [. .. ]
Job am 16.01.2026 bei JobMESH gefunden
PARI Pharma GmbH
Medical Affairs Manager (m/w/d)
• Bayern 82319 Starnberg
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] deren Angehörige dabei, ihr Leben zu erleichtern. Werden Sie Teil unserer Mission und gestalten Sie mit uns die Zukunft Bringen Sie Ihre Expertise am Standort Starnberg mit [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] ein als Medical Affairs Manager (m/w/d) in Vollzeit (Schwerpunkt: Klinische Bewertung Medizinprodukte) Als Medical Affairs Manager (m/w/d) übernehmen Sie eine zentrale Rolle bei der medizinisch-wissenschaftlichen Bewertung und Begleitung unserer Medizinprodukte insbesondere solcher, mit denen Arzneimittel vernebelt werden. Sie gestalten klinische Bewertungen eigenverantwortlich und stellen deren regulatorische Konformität über den gesamten Produktlebenszyklus sicher. Ihre Aufgaben im Überblick:Eigenverantwortliche Erstellung, Pflege und Aktualisierung von Clinical Evaluation Reports (CERs) gemäß MDR Erarbeitung von Clinical Evaluation Plans (CEP) sowie Post-Market Clinical Follow-up (PMCF) Plänen und Reports Bewertung und Zusammenfassung klinischer Daten aus Studien, Literatur und Post-Market-Daten Medizinisch-wissenschaftliche Unterstützung interner Stakeholder, insbesondere aus Forschung Entwicklung, Quality Management, Produktmanagement sowie Marketing Enge Mitarbeit in [. .. ] Guidelines und gesundheitspolitischer Entwicklungen Fachlicher Austausch mit externen Dienstleistern, ggf. Prüfstellen und weiteren Partnern Ihr Profil:Abgeschlossenes Studium der Medizin, Pharmazie oder Naturwissenschaften idealerweise ergänzt durch einen Master of Drug and Regulatory Affairs Mehrjährige praktische Erfahrung in der Erstellung klinischer Bewertungen für Medizinprodukte, bevorzugt im Umfeld von inhalativen/ respiratorischen Systemen Sehr gute Kenntnisse der MDR sowie der regulatorischen Anforderungen an CERs Erfahrung aus einem Dienstleistungsumfeld (z. B. Consulting, CRO, Regulatory Service Provider) von Vorteil Routine im Arbeiten in komplexen Projektstrukturen Erfahrung in [. .. ]
Job am 15.01.2026 bei Jooble gefunden
Philips
Senior Manager Clinical Development-Patient Monitoring
• Böblingen
JOB DESCRIPTION Job Title Senior
Manager Clinical Development-Patient Monitoring Job Description As an important member of our talented Hospital Patient Monitoring (HPM) Clinical
Affairs, the Senior Manager-Clinical Development is [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] responsible for managing the day-to-day operations of Clinical Measurements Specialty Monitoring clinical programs, improving efficiency and simplifying the planning/ execution of clinical plans. This role can be based either in Boblingen (Germany) or in Eindhoven (Netherlands) Your role: Responsible for planning, direction, [. .. ] and we won t stop until everybody everywhere has access to the quality healthcare that we all deserve. With patient safety and Quality as our fundamental premise, we focus on regulatory requirements and quality standards in our daily work. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. If youre interested in this role and have many, but not all, of the [. .. ]
Job am 14.01.2026 bei Jooble gefunden
Incyte Corporation
• München
Overview: Summary The (Senior) Medical
Manager Dermatology is part of the Medical
Affairs Inflammation Autoimmunity (IAI) Team and supports the development of the local medical strategy and medical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] plans within the therapeutic area of dermatology. The role provides a bridge between Clinical Development, Medical Affairs and the commercial organization. The (Senior) Medical Manager Dermatology will play a key role in developing and executing the medical and scientific (non-promotional) strategy for the German Immunology portfolio/ therapeutic area and will be involved in a wide range of activities for Incyte IAI drugs both [. .. ] on a national and international level Contributes positively to a strong culture of business integrity and ethics and embraces the Mission, Vision and Values of the organization Acts within compliance, regulatory and legal requirements as well as within company guidelines Requirements Relevant scientific degree (medicine, life sciences or equivalent) , MD or Ph D preferred 3-5 years medical affairs experience in the pharmaceutical industry Experience in Dermatology/ Immunology (preferred) and understanding of customer-and market needs Launch expertise within the company [. .. ]
Job am 14.01.2026 bei Jooble gefunden
Eraneos
(Senior) Manager Life Science R D (all genders)
• Hamburg
[. .. ] Europe and Globally. Digital Transformation Leadership: Drive the digital transformation of our clients by identify-ing and implementing innovative digital solutions in R D, with a focus on [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data AI, Clinical, Regulatory Affairs or Pharmacovigilance. Project Management and Team Leadership: Lead and manage multidisciplinary project teams, ensuring the successful delivery of high-quality consulting services. Foster a collab-orative, digitally-savvy team environment that promotes innovation and continuous improve-ment. Digital Tools Adoption: Support clients in adopting and integrating advanced digital tools and [. .. ]
Job am 14.01.2026 bei Jooble gefunden
Alexion Pharmaceuticals
Clinical Research Associate
• München
This is what you will do: The
Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at their assigned sites and is an active participant [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] in the local study team (s) . The CRA works in close collaboration with local team members (Project Management Clinical Operations (PMCO) , Study Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs in Clinical Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner on a site level. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to [. .. ] with ICH-GCP, Alexion SOPs and local requirements. Supporting/ participating in regular QC checks of the e TMF In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include collection, preparation, review and tracking of documents for the application process; submission of proper application/ documents to EC/ IRB and to Regulatory Authorities for start-up and for the duration of the study. Contributing to the nomination and selection of potential investigators and assisting with feasibility activities Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP) and other internal stakeholders, as needed. Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to Global Study team, Local study team, Country Operations Line Management and/or Quality Group, representatives as required. Preparing for and [. .. ]
Job am 14.01.2026 bei Jooble gefunden
Thermo Fisher Scientific
Local Clinical Trial Manager-FSP, Germany-6 month FTC (m/f/d)
• Homeoffice
[. .. ] safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing [...]
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[...] therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in [. .. ] protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer s time/ quality/ cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works on projects of low to moderate complexity and as part of a team of CTMs. A day in the Life: Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc. ) , vendor staff, and external clinical site staff involved in study preparation and delivery providing both matrix leadership and project management of study activities within the country (ies) . Serves as the operational point-of-contact between the central study team and within-country (ies) study team. The LDL collaborates closely with local medical and regulatory affairs staff to align local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within country (ies) . Leads selection of sites within country (ies) and is accountable for local study performance. Accountable for within-country delivery of assigned [. .. ]
Job am 14.01.2026 bei Jooble gefunden
ICON
Manager, Site Engagement Liaison
• Homeoffice
Work-Life-Balance
As a
Manager, Site Engagement Liaison, you will be joining the worlds largest most comprehensive
clinical research organisation, powered by healthcare intelligence. The Site Engagement Liaison Manager is [...]
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[...] a field based expert who supports the conduct and the patient recruitment of the client global clinical trials at investigative sites, through local and relational support. What you will be doing: Participate in study-level feasibility activities through [. .. ] such as accompanying the CRO CRA during site visits. This to ensure high quality conduct and execution of the clinical trials according to the protocol and ICH GCP and local regulatory requirements. Closely work together with the Medical Affairs colleagues, eg the MSLs to ensure optimal synergies in the respective site contacts and support. Optimize site engagement for a specific trial to ensure site engagement and quality for the site-level enrollment and execution of every trial. Oversee and track patient recruitment for the regional sites and pro-actively [. .. ]
Job am 17.01.2026 bei Neuvoo.com gefunden
PARI Pharma GmbH
Medical Affairs Manager (m/w/d)
• Bavaria Starnberg
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] deren Angehörige dabei, ihr Leben zu erleichtern. Werden Sie Teil unserer Mission und gestalten Sie mit uns die Zukunft Bringen Sie Ihre Expertise am Standort Starnberg mit [...]
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[...] ein als Medical Affairs Manager (m/w/d) in Vollzeit (Schwerpunkt: Klinische Bewertung Medizinprodukte) Als Medical Affairs Manager (m/w/d) übernehmen Sie eine zentrale Rolle bei der medizinisch-wissenschaftlichen Bewertung und Begleitung unserer Medizinprodukte insbesondere solcher, mit denen Arzneimittel vernebelt werden. Sie gestalten klinische Bewertungen eigenverantwortlich und stellen deren regulatorische Konformität über den gesamten Produktlebenszyklus sicher. Ihre Aufgaben im Überblick Eigenverantwortliche Erstellung, Pflege und Aktualisierung von Clinical Evaluation Reports (CERs) gemäß MDR Erarbeitung von Clinical Evaluation Plans (CEP) sowie Post-Market Clinical Follow-up (PMCF) Plänen und Reports Bewertung und Zusammenfassung klinischer Daten aus Studien, Literatur und Post-Market-Daten Medizinisch-wissenschaftliche Unterstützung interner Stakeholder, insbesondere aus Forschung Entwicklung, Quality Management, Produktmanagement sowie Marketing Enge Mitarbeit in [. .. ] und gesundheitspolitischer Entwicklungen Fachlicher Austausch mit externen Dienstleistern, ggf. Prüfstellen und weiteren Partnern Ihr Profil Abgeschlossenes Studium der Medizin, Pharmazie oder Naturwissenschaften idealerweise ergänzt durch einen Master of Drug and Regulatory Affairs Mehrjährige praktische Erfahrung in der Erstellung klinischer Bewertungen für Medizinprodukte, bevorzugt im Umfeld von inhalativen/ respiratorischen Systemen Sehr gute Kenntnisse der MDR sowie der regulatorischen Anforderungen an CERs Erfahrung aus einem Dienstleistungsumfeld (z. B. Consulting, CRO, Regulatory Service Provider) von Vorteil Routine im Arbeiten in komplexen Projektstrukturen Erfahrung in [. .. ]
Job gestern bei Jooble gefunden
Clinical Trial Managers (SMLs) sponsor dedicated in Germany
• München
Clinical Trial Managers (SMLs) sponsor dedicated in Germany Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical
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[...] class=highlight_text>affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, [. .. ] to work for. Why Syneos Health supportive and engaged line management; Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/ GCP/
regulatory compliance and data integrity. May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT) . Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/ Ce Ms) is aware of the contractual obligations and parameters. Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates to the project
manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation [. .. ]
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Wieviel verdient man als Clinical Regulatory Affairs Manager pro Jahr?
Als Clinical Regulatory Affairs Manager verdient man zwischen EUR 60.000,- bis EUR 90.000,- im Jahr.
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Wieviele Unternehmen suchen nach Bewerbern für Clinical Regulatory Affairs Manager Jobs?
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Welche Unternehmen suchen nach Bewerbern für Clinical Regulatory Affairs Manager Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Clinical Regulatory Affairs Manager Stellenangebote:
- PARI Pharma GmbH (8 Jobs)
- Abb Vie (6 Jobs)
- HARTMANN (6 Jobs)
- Jazz Pharmaceuticals (6 Jobs)
- Stryker (4 Jobs)
- Regeneron (4 Jobs)
In welchen Bundesländern werden die meisten Clinical Regulatory Affairs Manager Jobs angeboten?
Die meisten Stellenanzeigen für Clinical Regulatory Affairs Manager Jobs werden derzeit in Bayern (37 Jobs), Baden-Württemberg (14 Jobs) und Berlin (13 Jobs) angeboten.
Zu welchem Berufsfeld gehören Clinical Regulatory Affairs Manager Jobs?
Clinical Regulatory Affairs Manager Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
