16 Jobs für Regulatory Reporting in Freiburg im Breisgau
Stellenangebote Regulatory Reporting in Freiburg im Breisgau Jobs
Job vor 2 Tagen bei StepStone gefunden
Dr. Falk Pharma GmbH
• Freiburg im Breisgau
Führungs-/ Leitungspositionen Homeoffice möglich
[. .. ] area. GL collaborates with Clinical Research teams from other therapeutic areas and serves as a key liaison between Clinical Research Gastroenterology II, Global Safety, Pre-and Early Clinical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Research, and Regulatory and Medical Affairs. GL drives execution for assigned projects in collaboration with other cross-functional stakeholders. Key Responsibilities Line manager for the organization/ project management of clinical studies in the Gastro II department Transfer of project responsibilities to assigned employees Review and approval of critical development documents (e. g. , [. .. ] (e. g. , CRO, central laboratory) Review and approval of investigator and vendor contracts (e. g. , CRO, central laboratory) Regular meetings within the Gastro II department (Clinical Operations) Monthly reporting to the Head of Clinical Research Support for the Head of Clinical Research in preparing and updating clinical development plans Cross-functional support in the clinical assessment of research and/or study proposals, development offers, and Go/ No-Go decisions in clinical development Organization of and participation in Steering Committee [. .. ]
Job vor 13 Tagen bei Jobleads gefunden
• Freiburg im Breisgau, Baden- Württemberg
Führungs-/ Leitungspositionen
[. .. ] more information about Enovis, please visit Was Sie tun werden What Youll Do Oversees the direction, planning, execution and interpretation of clinical trials/ research and data collection [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] activities along with regulatory compliance, patient safety and emerging patient risks. May establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Provides input on clinical study design, execution, and data analysis. Leads the adverse event reporting and safety responsibilities monitoring. Coordinates and develops information for reports submitted to regulatory agencies. Monitors adherence to protocols and determines study completion. May recruit clinical investigators and negotiate study design and costs. May act as consultant/ liaison with other corporations when working under licensing agreements. Establishes strategic plans and objectives. [. .. ]
Neu Job heute bei Jobleads gefunden
Clinical Research-Head of Gastroenterology II (m/f/d)
• Freiburg im Breisgau, Baden- Württemberg
Führungs-/ Leitungspositionen
[. .. ] therapeutic area. GL collaborates with Clinical Research teams from other therapeutic areas and serves as a key liaison between Clinical Research Gastroenterology II, Global Safety, Preand Early [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Clinical Research, and Regulatory and Medical Affairs. GL drives execution for assigned projects in collaboration with other crossfunctional stakeholders. Key Responsibilities Line manager for the organization/ project management of clinical studies in the Gastro II department Transfer of project responsibilities to assigned employees Review and approval of critical development documents (e. g. , Clinical [. .. ] (e. g. , CRO, central laboratory) Review and approval of investigator and vendor contracts (e. g. , CRO, central laboratory) Regular meetings within the Gastro II department (Clinical Operations) Monthly reporting to the Head of Clinical Research Support for the Head of Clinical Research in preparing and updating clinical development plans Crossfunctional support in the clinical assessment of research and/or study proposals, development offers, and Go/ No Go decisions in clinical development Organization of and participation in Steering Committee meetings [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
• Freiburg im Breisgau, Baden- Württemberg
[. .. ] are mitigated in the product quality plans. Identify critical elements of designs. Recommend design processes and methods to meet quality goals: DFX, etc. Provide guidance to other [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products. Plan and create quality standards, quality control, and quality assurance procedures, plans, test methods, fixtures, and processes for incoming materials and finished devices. Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data. Analyze and disposition of discrepant material. Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, inspection method qualification, and defect containments. Support development and execution of process validation and verification test plans, protocols, and reports. Support development and execution of manufacturing line qualification plans, protocols, [. .. ]
Job am 11.03.2026 bei Jobleads gefunden
• Freiburg im Breisgau, Baden- Württemberg
Position Summary At Stryker patient safety is a primary concern, and as PMS/ Vigilance group within the RAQA function it is a must to ensure compliancy to all
regulatory requirements [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] to safeguard prevention of patient risks. Partnering the business by meeting and exceeding customers expectations. Partnering with associated Governing and Regulatory Certification Authorities. Develops and applies intermediate knowledge and understanding of the PMS frameworks, legislative requirements, processes and procedures in the EMEA distribution organization. What you will do: Very [. .. ] customer acceptance. Responsible for assembling a team to work with, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely system deployment-having in consideration no direct reporting line cooperation. Measure system/s performance using appropriate tools and techniques in order to monitor the useability, any variances, perform any required corrective actions, and communicate to all stakeholders. Provides support to EMEA/ Country RAQA teams as appropriate. Acts as a regional subject matter expert. Increased participation within working groups [. .. ]
Job am 28.02.2026 bei Jobleads gefunden
• Freiburg im Breisgau, Baden- Württemberg
Führungs-/ Leitungspositionen
[. .. ] contraindications, as well as indications of quality defects, misuse, long-term use, abuse or counterfeit drugs Medical/ scientific assessment of drug risks and their documentation, taking into account [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] the statutory reporting obligations to the competent authorities Passing on necessary information to pharmacovigilance departments at service providers, licensees/ licensors, distribution partners and affiliates within the framework of contractual pharmacovigilance agreements Support with periodic reconciliations with partners, subsidiaries and internal departments Support in the preparation of pharmacovigilance agreements Support in creation and maintenance [. .. ] periodic safety reports (PSUR/ DSUR) Preparation of risk management plans including the coordination of risk-minimizing measures Approval and release of PASS protocols Support and advice in the preparation of regulatory submissions Contact person for the competent EU/ UK authorities on a 24/ 7 basis Contact person for GVP inspections Supervision of interventional and non-interventional studies, as well as other data collection activities including preparation and review of study-specific documents Benefits Supportive, respectful and appreciative work atmosphere in a [. .. ]
Job am 13.01.2026 bei Jobleads gefunden
• Freiburg im Breisgau, Baden- Württemberg
Homeoffice möglich
Join Our Team as a Quality Engineer As a (Senior) Quality Engineer (m/f/d) you will be responsible for Adverse Event
Reporting, focusing on MDRs, as well as playing a [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] crucial role in Stryker Leibinger Instruments Recall/ FSCA processes, ensuring product safety and compliance within the global regulatory Post Market landscape. What will you do You will be responsible for creating and submitting MDRs in compliance with FDAs CFR 21, part 803 requirements (Medical Device Reporting) . You will review, assess and keep overview of all incoming and open product complaints that need to be evaluated for reportability [. .. ]
Neu Job heute bei Neuvoo.com gefunden
Dr Falk Pharma
Clinical Research-Head of Gastroenterology II (m/f/d)
• Freiburg im Breisgau
Führungs-/ Leitungspositionen
[. .. ] area. GL collaborates with Clinical Research teams from other therapeutic areas and serves as a key liaison between Clinical Research Gastroenterology II, Global Safety, Pre-and Early Clinical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Research, and Regulatory and Medical Affairs. GL drives execution for assigned projects in collaboration with other cross-functional stakeholders. Key Responsibilities Line manager for the organization/ project management of clinical studies in the Gastro II department Transfer of project responsibilities to assigned employees Review and approval of critical development documents (e. g. , [. .. ] (e. g. , CRO, central laboratory) Review and approval of investigator and vendor contracts (e. g. , CRO, central laboratory) Regular meetings within the Gastro II department (Clinical Operations) Monthly reporting to the Head of Clinical Research Support for the Head of Clinical Research in preparing and updating clinical development plans Cross-functional support in the clinical assessment of research and/or study proposals, development offers, and Go/ No-Go decisions in clinical development Organization of and participation in Steering Committee [. .. ]
Job vor 2 Tagen bei Neuvoo.com gefunden
Confidential
Clinical Research-Head of Gastroenterology II (m/f/d)
• Freiburg im Breisgau
Führungs-/ Leitungspositionen
[. .. ] area. GL collaborates with Clinical Research teams from other therapeutic areas and serves as a key liaison between Clinical Research Gastroenterology II, Global Safety, Pre-and Early Clinical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Research, and Regulatory and Medical Affairs. GL drives execution for assigned projects in collaboration with other cross-functional stakeholders. Key Responsibilities Line manager for the organization/ project management of clinical studies in the Gastro II department Transfer of project responsibilities to assigned employees Review and approval of critical development documents (e. g. , [. .. ] (e. g. , CRO, central laboratory) Review and approval of investigator and vendor contracts (e. g. , CRO, central laboratory) Regular meetings within the Gastro II department (Clinical Operations) Monthly reporting to the Head of Clinical Research Support for the Head of Clinical Research in preparing and updating clinical development plans Cross-functional support in the clinical assessment of research and/or study proposals, development offers, and Go/ No-Go decisions in clinical development Organization of and participation in Steering Committee [. .. ]
Job vor 5 Tagen bei Neuvoo gefunden
Dr. Falk Pharma GmbH
Clinical Research-Head of Gastroenterology II (m/f/d)
• Freiburg im Breisgau, Baden- Württemberg
Führungs-/ Leitungspositionen
[. .. ] area. GL collaborates with Clinical Research teams from other therapeutic areas and serves as a key liaison between Clinical Research Gastroenterology II, Global Safety, Pre-and Early Clinical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Research, and Regulatory and Medical Affairs. GL drives execution for assigned projects in collaboration with other cross-functional stakeholders. Key Responsibilities Line manager for the organization/ project management of clinical studies in the Gastro II department Transfer of project responsibilities to assigned employees Review and approval of critical development documents (e. g. , [. .. ] (e. g. , CRO, central laboratory) Review and approval of investigator and vendor contracts (e. g. , CRO, central laboratory) Regular meetings within the Gastro II department (Clinical Operations) Monthly reporting to the Head of Clinical Research Support for the Head of Clinical Research in preparing and updating clinical development plans Cross-functional support in the clinical assessment of research and/or study proposals, development offers, and Go/ No-Go decisions in clinical development Organization of and participation in Steering Committee [. .. ]
Job am 08.03.2026 bei Neuvoo gefunden
Stryker Romania Srl
Senior Project Manager, Post Market Surveillance, EMEA
• Freiburg im Breisgau, Baden- Württemberg
[. .. ] Flexibility: Hybrid Position Summary At Stryker patient safety is a primary concern, and as PMS/ Vigilance group within the RAQA function it is a must to ensure [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] compliancy to all regulatory requirements to safeguard prevention of patient risks. Partnering the business by meeting and exceeding customers expectations Partnering with associated Governing and Regulatory Certification Authorities Develops and applies intermediate knowledge and understanding of the PMS frameworks, legislative requirements, processes and procedures in the EMEA distribution organization. What you will do: Very [. .. ] customer acceptance. Responsible for assembling a team to work with, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely system deployment-having in consideration no direct reporting line cooperation Measure system/s performance using appropriate tools and techniques in order to monitor the useability, any variances, perform any required corrective actions, and communicate to all stakeholders. Provides support to EMEA/ Country RAQA teams as appropriate. Acts as a regional subject matter expert Increased participation within working groups [. .. ]
Job am 22.02.2026 bei Neuvoo gefunden
Job Rad
Teamleitung Digital Risk Resilience inkl. Informationssicherheitsbeauftragte:r (m/w/d)
• Freiburg im Breisgau, Baden- Württemberg
Führungs-/ Leitungspositionen Abgeschlossenes Studium
[. .. ] eigenen Mitarbeiter:innen abgedeckt. Das erwartet dich Führung ISB : Du verantwortest die Weiterentwicklung des Teams mit den Themen für IKT-Risikomanagement, Informationssicherheit, BCM, Datenschutz und übernimmst die Funktion [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] des Informationssicherheitsbeauftragten Regulatory Control Framework : Du entwickelst die Managementsysteme, insbesondere das IKT-Risikomanagement, methodisch und organisatorisch weiter und stellst die Einhaltung der regulatorischen Anforderungen (z. B. DORA, Ma Risk, DSGVO) sicher Risiko-Sicherheitsprozesse : Du gestaltest gemeinsam mit deinem Team die IKT-Risiko-, Sicherheits-, Resilienz- und Datenschutzprozesse in enger Zusammenarbeit [. .. ] den Fachbereichen und externen Partnern Schulung Awareness : Du förderst eine unternehmensweite Sicherheits- und Resilienzkultur durch Schulungen, Awarenessmaßnahmen und der engen Zusammenarbeit mit der IT, Fachbereichen und weiteren Governance-Funktionen Reporting Stakeholdermanagement : Du etablierst effektive Reporting- und Monitoringstrukturen auf Managementebene und vertrittst deinen Verantwortungsbereich gegenüber Aufsicht, Prüfern und externen Partnern Das bringst du mit Fachliche Qualifikation : Abgeschlossenes Studium z. B. in Informatik, Wirtschaftsinformatik, IT-Security, Cyber Security, Recht (IT-/ Datenschutz) , BWL oder vergleichbar oder eine gleichwertige Qualifikation mit [. .. ]
Job am 15.02.2026 bei Neuvoo gefunden
Dr. Falk Pharma GmbH
Quality Assurance GVP Manager (m/w/d)
• Freiburg im Breisgau, Baden- Württemberg
[. .. ] a pivotal role in maintaining and enhancing the quality management framework in alignment with Good Pharmacovigilance Practice (GVP) guidelines. By collaborating with internal teams and external partners, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] you will ensure regulatory compliance and foster a robust culture of vigilance and safety. Your primary responsibilities will include, but are not limited to: Audits and Inspections: Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits) , ensuring adherence to company standards and [. .. ] Preventive Actions (CAPA) specific to PV (internal or external) Training and Knowledge Development: Design and deliver training programs on pharmacovigilance quality principles to ensure staff proficiency and compliance Documentation and Reporting: Maintain accurate QA GVP documentation: Ensure that all QA documentation related to GV Pincluding audit reports and CAPA plansis accurate, up-to-date, and readily accessible Your qualification A minimum of 4-5 years of experience in pharmacovigilance quality assurance or related fields within the pharmaceutical industry, a Health Authority [. .. ]
Job am 15.02.2026 bei Neuvoo gefunden
Dr. Falk Pharma GmbH
Quality Assurance GCP Manager (m/w/d)
• Freiburg im Breisgau, Baden- Württemberg
[. .. ] a pivotal role in maintaining and enhancing the quality management framework in alignment with Good Clinical Practice (GCP) guidelines. Collaborating closely with internal teams and external partners, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] you will ensure regulatory compliance and promote a robust culture of vigilance and safety. Your primary responsibilities will include, but are not limited to: Audit, Inspection, and Deviation Management: Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence [. .. ] Risk Mitigation Strategies at all levels Training and Knowledge Development: Develop and implement targeted training programs on GCP and quality assurance principles to ensure staff proficiency and compliance Documentation and Reporting: Analyse and present quality metrics and audit findings to senior management to support decision-making Your qualification A minimum of 4-5 years of experience in GCP quality assurance or related fields within the pharmaceutical industry or a Health Authority Degree in Life Sciences, Pharmacy or a related field Extensive [. .. ]
Job am 06.02.2026 bei Neuvoo gefunden
Dr. Falk Pharma GmbH
Head of Global Safety Product Leads-Risk Label Management (m/f/d)
• Freiburg im Breisgau, Baden- Württemberg
Führungs-/ Leitungspositionen
[. .. ] contraindications, as well as indications of quality defects, misuse, long-term use, abuse or counterfeit drugs Medical/ scientific assessment of drug risks and their documentation, taking into account [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] the statutory reporting obligations to the competent authorities Passing on necessary information to pharmacovigilance departments at service providers, licensees/ licensors, distribution partners and affiliates within the framework of contractual pharmacovigilance agreements Support with periodic reconciliations with partners, subsidiaries and internal departments Support in the preparation of pharmacovigilance agreements Support in creation and maintenance [. .. ] periodic safety reports (PSUR/ DSUR) Preparation of risk management plans including the coordination of risk-minimizing measures Approval and release of PASS protocols Support and advice in the preparation of regulatory submissions Contact person for the competent EU/ UK authorities on a 24/ 7 basis Contact person for GVP inspections Supervision of interventional and non-interventional studies, as well as other data collection activities including preparation and review of study-specific documents Your qualification Successfully completed degree in pharmacy or human [. .. ]
Job am 18.01.2026 bei Neuvoo gefunden
Stryker Leibinger GmbH Co. KG
Quality Engineer/ Senior Quality Engineer (m/f/d) Post Market Surveillance
• Freiburg im Breisgau, Baden- Württemberg
Homeoffice möglich
Work Flexibility: Hybrid or Onsite Join Our Team as a Quality Engineer As a (Senior) Quality Engineer (m/f/d) in Freiburg, you manage complaints and adverse event
reporting for Leibinger [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Instruments, ensuring safety and compliance as part of the Post-Market Surveillance team. What you will do Investigate reported field cases, addressing both technical and clinical issues with input from relevant experts. Prepare and submit Adverse Event Reports according to EUMDR and FDA CFR 21, part 803 standards. Evaluate each case based on investigation results, risk assessments, and manufacturing data while collaborating with Quality, R D, Manufacturing, Regulatory Affairs, and Clinical Affairs partners. Analyze data independently to identify failure modes, root causes, and trends. Participate in operational, cross-functional projects to improve products and act as the key contact regarding your product portfolios performance in the field. You will be responsible for preparing and coordinating Recalls/ FSCAs in [. .. ]
Häufig gestellte Fragen
Wieviele offene Stellenangebote gibt es für Regulatory Reporting Jobs in Freiburg im Breisgau bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 16 offene Stellenanzeigen für Regulatory Reporting Jobs in Freiburg im Breisgau.
Zu welchem Berufsfeld gehören Regulatory Reporting Jobs in Freiburg im Breisgau?
Regulatory Reporting Jobs in Freiburg im Breisgau gehören zum Berufsfeld Regulatory Affairs & Management.
