19 Jobs für Quality Manager Ivdr
Stellenangebote Quality Manager Ivdr Jobs
Job vor 10 Tagen bei Mindmatch.ai gefunden
Flinn. ai
• AT- 9 Wien
As a Senior Regulatory Affairs Specialist, you are Flinns in-house regulatory domain expert. You deliver high-
quality regulatory intelligence services directly to our Med Tech customers across a broad range of [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] regulatory challenges monitoring new regulations, identifying gaps, interpreting requirements, and supporting market expansion. This is a generalist role by design : you will work across different regulatory frameworks, across MDSAP and EU geographies, with a broad variety of device categories. You will work inside the Product Tech team, alongside our Product Manager feeding your field expertise and customer observations as a knowledgeable domain partner, while the PM owns the product direction. You bring the regulatory know-how; they translate it into software. Over time, you will help codify your expertise into Flinns AI-powered platform by working systematically with our tools and [. .. ] global regulatory landscape new regulations, revised standards, updated guidances, and enforcement trends across multiple geographies and device categories. Evaluate and interpret complex regulatory documents (primary focus on MDSAP EU: MDR/ IVDR, FDA, PMDA, TGA, ISO standards, and associated guidances) , extract applicable requirements, and deliver clear, actionable briefings to customers. Proactively alert customers to changes relevant to their device portfolios before deadlines become urgent. Identify gaps in customers existing regulatory monitoring and compliance programmes, and recommend systematic ways to close them. [. .. ]
Job am 10.03.2026 bei Mindmatch.ai gefunden
Ketryx
• AT- 9 Wien
Führungs-/ Leitungspositionen
[. .. ] 90, 000 EUR gross base salary + performance-based bonus and equity options. Compensation may be negotiated based on experience level. As a Ketryx QA/ RA Lead, you [...]
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[...] will lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-powered compliance platform. This is a rare opportunity to shape the future of regulatory affairs. Youll have the autonomy and expertise to drive repeatable QMS deployment processes while helping shape the future [. .. ] Responsibilities Lead Quality Management System (QMS) setup and deployment for medical device clients Own and manage QMS templates and regulatory compliance frameworks Provide expert consulting on ISO 13485, EU MDR/ IVDR, UKCA, Gx P, and other quality systems standards Scale operations to support highgrowth clients Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance Drive and/or support internal and external audit programs, customer audits and regulatory inspections. Orchestrate the continuous validation lifecycle, including drafting, reviewing, and approving documentation [. .. ] in regulatory affairs Keywords ISO 13485, EU MDR/ IVDR UKCA, Quality Management System (QMS) , Management representative, Medical device quality, Stryker, Medtronic, Boston Scientific, QMS setup, Regulatory consulting, Quality systems manager, Computer software validation, Cybersecurity, Usability, Startup experience, Series A/ B, Vienna/ Austria, Consulting firms, Quality assurance, Medical device industry What We Offer Competitive compensation Work in an exciting field with a positive impact on the world Opportunity to learn and grow as part of a global team Generous PTO for [. .. ]
Job gestern bei Jobleads gefunden
• Berlin
#
Quality Manager in Regulatory Affairs (f/m/d) Posted on January 21, 2026 (2 months ago) # What we do At Vara, we believe better breast cancer detection should be a [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] standard offering for every woman, everywhere. Our AI-powered software platform, developed in close collaboration with radiologists in Germany, leads to [. .. ] of QMS, CAPA, Management Reviews, and risk management (especially ISO 14971) . Familiarity with AI/ ML validation, software development workflows, and lifecycle management. Experience with regulatory submissions and audits (MDR, IVDR, MDSAP, FDA Sa MD Guidance, IMDRF) . Nice to have: Certified Auditor for ISO 13485 (additional ISO 27001, ISO 9001 a plus) . Experience in cybersecurity, data privacy (GDPR, HIPAA, IEC 81001, IEC 27001) . Understanding of AI/ ML-specific regulatory requirements (e. g. , GMLP, EU AI Act) . Prior [. .. ]
Job vor 10 Tagen bei Jobleads gefunden
Senior Regulatory Affairs Specialist
• Wien
As a Senior Regulatory Affairs Specialist, you are Flinns in-house regulatory domain expert. You deliver high-
quality regulatory intelligence services directly to our Med Tech customers across a broad range of [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] regulatory challenges monitoring new regulations, identifying gaps, interpreting requirements, and supporting market expansion. This is a generalist role by design : you will work across different regulatory frameworks, across MDSAP and EU geographies, with a broad variety of device categories. You will work inside the Product Tech team, alongside our Product Manager feeding your field expertise and customer observations as a knowledgeable domain partner, while the PM owns the product direction. You bring the regulatory know-how; they translate it into software. Over time, you will help codify your expertise into Flinns AI-powered platform by working systematically with our tools and [. .. ] global regulatory landscape new regulations, revised standards, updated guidances, and enforcement trends across multiple geographies and device categories. Evaluate and interpret complex regulatory documents (primary focus on MDSAP EU: MDR/ IVDR, FDA, PMDA, TGA, ISO standards, and associated guidances) , extract applicable requirements, and deliver clear, actionable briefings to customers. Proactively alert customers to changes relevant to their device portfolios before deadlines become urgent. Identify gaps in customers existing regulatory monitoring and compliance programmes, and recommend systematic ways to close them. [. .. ]
Job vor 11 Tagen bei Jobleads gefunden
• Zug
[. .. ] their mitigations Planning and controlling the project budget and resources Monitor the progress of the project against the project plan and ensure the timely delivery of work [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] packages and their quality, also with external partners Leading and managing the project team with matrix organization Strong collaboration with internal stakeholders suppliers Your background: Sc. or B. Sc. degree in Engineering, Natural Science or related disciplines (Ph D also ok) 5 years of relevant work experience in IVD product development and production engineering Knowledge of Process Management methodologies (Lean, Six Sigma, etc. ) and in-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820 etc. Experience in external manufacturing collaborations Ability to think strategically and systemically, willingness to try new ideas and participate in changes Strong leadership skills including the ability to get things done with a proven track record of consensus building and conflict management in challenging situations [. .. ]
Job vor 11 Tagen bei Jobleads gefunden
Project Manager-External Manufacturing
• Rotkreuz, Zug
[. .. ] their mitigations Planning and controlling the project budget and resources Monitor the progress of the project against the project plan and ensure the timely delivery of work [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] packages and their quality, also with external partners Leading and managing the project team with matrix organization Strong collaboration with internal stakeholders suppliers Your background: Sc. or B. Sc. degree in Engineering, Natural Science or related disciplines (Ph D also ok) 5 years of relevant work experience in IVD product development and production engineering Knowledge of Process Management methodologies (Lean, Six Sigma, etc. ) and in-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820 etc. Experience in external manufacturing collaborations Ability to think strategically and systemically, willingness to try new ideas and participate in changes Strong leadership skills including the ability to get things done with a proven track record of consensus building and conflict management in challenging situations [. .. ]
Job am 28.02.2026 bei Jobleads gefunden
• Karlsruhe, Baden- Württemberg
Senior Clinical Project
Manager (m/w/d) - Remote Full-time Position Type: Permanent Working within the Global Clinical Affairs (GCA) organization, the Senior Clinical Project Manager is responsible for clinical trial management [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] of multiple studies and may be subject matter expert for group or platform of assigned clinical studies including the planning, implementation, [. .. ] leads and trains study-specific local clinical resources, e. g. contractor CRA, CRO, etc. Provides critical thinking and escalates accordingly when issues arise during execution of clinical studies. Oversees study quality and implements high quality standards in order to meet compliance requirements Contributes to continuous improvement activities/ initiatives, Manages relationships with sites/ PIs and other study-related vendors, e. g. CROs, central labs, etc. Develop and/or oversee the development of clinical study budgets, including invoice review/approval and monthly accruals [. .. ] other standards Demonstrable Project Management skills; PMP Certification is a preferred goal for all Clinical Project Managers; Proficient understanding of Good Clinical Practice (GCP) , FDA and ISO regulations, MDR/ IVDR and current industry practices related to the conduct of clinical studies Knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulations Strong client and vendor relationship management skills Ability to work effectively, mostly independently in international teams, manage multiple projects and work in a fast paced [. .. ]
Job am 26.01.2026 bei Jobleads gefunden
• Bensheim, Hessen
Flexible Arbeitszeiten Betriebliche Altersvorsorge 30+ Urlaubstage
[. .. ] Audits am Standort Bensheim Qualifikationen Erfolgreich abgeschlossenes Hochschulstudium mit technischem Hintergrund (Maschinenbau, Elektrotechnik, Wirtschaftsingenieurwesen, Qualitätsmanagement) oder vergleichbar Erste Erfahrungen im Qualitätsmanagement in einem Unternehmen mit zertifiziertem Qualitätsmanagementsystem, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] idealerweise aus MDR/ IVDR-Umfeld. Solide Kenntnisse der Vorschriften für Medizinprodukte wie FDA Q System Regulation, MDR und der geltenden Industrienormen wie ISO/ ANSI 13485, ISO 14971, IEC 62304 und anderer insbesondere mit Blick auf Design Control-Vorgaben Erfahrungen im Umgang mit internationalen Zulassungsanforderungen (wie beispielsweise FDA 510k, Letter to File ) Fähigkeit, durch [. .. ]
Job am 25.01.2026 bei Jobleads gefunden
Design Quality Manager (m/w/d)
• Bensheim, Hessen
Flexible Arbeitszeiten Betriebliche Altersvorsorge 30+ Urlaubstage
[. .. ] moderne Patientenversorgung auf globaler Ebene weiter vorantreiben. Unsere Aktien sind an der US-Technikbörse NASDAQ unter dem Kürzel XRAY notiert. Wir suchen eine/n erfahrene/ n und talentierte/ n [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Design Quality Manager DQM (m/w/d ) zur Verstärkung unseres Teams. hre Aufgaben: Überwachung und fachliche Begleitung von Validierungs- und Verifizierungsaktivitäten (V V) im Rahmen der Produktentwicklung gemäß Design-Control-Vorgaben Sicherstellung der Einhaltung und kontinuierliche Weiterentwicklung von Design-Control- und Qualitätsmanagementprozessen Entwicklung, Implementierung und Etablierung von Qualitätsstrategien, Standards und Best Practices [. .. ] QMS-Audits am Standort Bensheim Erfolgreich abgeschlossenes Hochschulstudium mit technischem Hintergrund (Maschinenbau, Elektrotechnik, Wirtschaftsingenieurwesen, Qualitätsmanagement) oder vergleichbar Erste Erfahrungen im Qualitätsmanagement in einem Unternehmen mit zertifiziertem Qualitätsmanagementsystem, idealerweise aus MDR/ IVDR-Umfeld Solide Kenntnisse der Vorschriften für Medizinprodukte wie FDA Q System Regulation, MDR und der geltenden Industrienormen wie ISO/ ANSI 13485, ISO 14971, IEC 62304 und weiterer insbesondere mit Blick auf Design Control-Vorgaben Erfahrungen im Umgang mit internationalen Zulassungsanforderungen (wie beispielsweise FDA 510k, Letter to file, ) Fähigkeit, durch [. .. ]
Job am 22.01.2026 bei Jobleads gefunden
• Berlin
About the Role As
Quality Manager in Regulatory Affairs, you will be responsible for maintaining and continuously improving the companys Quality Management System (QMS) , ensuring compliance with ISO 13485 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and applicable regulatory requirements. You will coordinate updates to key SOPs and processes, support internal audits, data privacy, and IT security, and act as the person [. .. ] knowledge of QMS, CAPA, Management Reviews, and risk management (esp. ISO 14971) Familiarity with AI/ ML validation, software development workflows, and lifecycle management Experience with regulatory submissions and audits (MDR, IVDR, MDSAP, FDA Sa MD Guidance, IMDRF) Nice to have: Certified Auditor for ISO 13485 (additional ISO 27001, ISO 9001 as a plus) Experience in cybersecurity, data privacy (GDPR, HIPAA, IEC 81001, IEC 27001) Understanding of AI/ ML-specific regulatory requirements (e. g. , GMLP, EU AI Act) Prior experience in startup [. .. ]
Job am 24.03.2026 bei Neuvoo gefunden
Genomic Health, Inc.
Lead Regulatory Affairs Manager, International
Führungs-/ Leitungspositionen
Position Overview The Lead Regulatory Affairs
Manager, International will support or lead the creation and submission of product Technical Files/ Standard Technical Documentation and other submission related documents for market [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new [. .. ] requirements and Exact Sciences Medical, Legal and Regulatory (MLR) review process. Demonstrate continuous pursuit of global regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including IVDR, UK CA, FDA and Health Canada regulations and policies applying to In Vitro Diagnostic medical devices including, PMAs, 510 (k) s, labeling and promotional materials, global registration, and technical writing. Experience with regulators in the Middles East and/or Latin America will be a plus. Strong technical writing skills. Effective [. .. ] and reporting problems or concerns relating to job functions. Conduct self in a professional manner with coworkers, management, customers, and others. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the companys Quality Management System policies and procedures. Regular and reliable attendance. Ability to work designated schedule. Ability to work nights and/or weekends as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform [. .. ]
Job am 22.03.2026 bei Neuvoo gefunden
Genomic Health, Inc.
Lead Regulatory Affairs Manager, International
• Cologne, North Rhine- Westphalia
Führungs-/ Leitungspositionen
Position Overview The Lead Regulatory Affairs
Manager, International will support or lead the creation and submission of product Technical Files/ Standard Technical Documentation and other submission related documents for [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] market authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new [. .. ] requirements and Exact Sciences Medical, Legal and Regulatory (MLR) review process. Demonstrate continuous pursuit of global regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including IVDR, UK CA, FDA and Health Canada regulations and policies applying to In Vitro Diagnostic medical devices including, PMAs, 510 (k) s, labeling and promotional materials, global registration, and technical writing. Experience with regulators in the Middles East and/or Latin America will be a plus. Strong technical writing skills. Effective [. .. ] and reporting problems or concerns relating to job functions. Conduct self in a professional manner with coworkers, management, customers, and others. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the companys Quality Management System policies and procedures. Regular and reliable attendance. Ability to work designated schedule. Ability to work nights and/or weekends as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform [. .. ]
Job am 07.03.2026 bei Neuvoo gefunden
anvajo GmbH
Senior Project Portfolio Manager (m/f/d)
• Dresden, Saxony
Jobticket
Full-time/ part-time (min. 35h/ week) Team Lead Project Management On-site in Dresden with option for mobile work Are you an experienced project
manager who enjoys looking beyond individual projects [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and managing a portfolio from a strategic perspective? Do you want to represent the voice of project management at the management level and support decision-making on priorities and resources? Are you motivated to mentor project managers, promote pragmatic planning, and strengthen project management [. .. ] in strategic decisions Project Management Support Governance Provide senior PM guidance to project managers and promote pragmatic, efficient planning approaches Review project plans, timelines, and outputs with a critical and quality-focused perspective Support planning, prioritization, and continuous improvement of PM processes Team Development Mentor and develop the project management team Foster knowledge sharing within the PM team and identify training needs Own Project Responsibility Lead selected development projects from concept to market launch Your profile Degree in Engineering, Business Administration, [. .. ] management approaches Strong leadership, communication, and stakeholder management skills Structured, pragmatic, and solution-oriented mindset Fluent English required, German is a plus Experience in regulated environments (e. g. , MDR/ IVDR, FDA, ISO 13485) is beneficial Your benefits Exciting projects responsibility from day one 30 days of paid vacation My Flex Time for extra time off Flexible working hours mobile office option One team day per half-year, complemented by company events throughout the year to strengthen team spirit Competitive salary [. .. ]
Job am 06.02.2026 bei Neuvoo gefunden
Sanner GmbH
Quality Manager (m/w/d) Operations, Quality Manager (m/w/d) Operations bei Sanner GmbH softgarden
• Bensheim, Hessen
Flexible Arbeitszeiten 30+ Urlaubstage Work-Life-Balance
Quality Manager (m/w/d) Operations bei Sanner Gmb H softgarden View job here Quality Manager (m/w/d) Operations Vollzeit Hybrid 64625 Bensheim, Deutschland Mit Berufserfahrung 04.02.26 Quality Manager (m/w/d) Operations Qualität, Innovationskraft, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Knowhow, Leidenschaft und Fairness-sind Sie motiviert, diese Werte mitzutragen? Die Sanner Gruppe ist ein [. .. ] Studium oder vergleichbare Ausbildung mit mehrjähriger Berufserfahrung Mehrjährige praktische Erfahrung im Qualitätsmanagement/ Operations, idealerweise in der Medizinprodukte-oder Pharmaindustrie bzw. Primärpackmittelproduktion Fundierte Kenntnisse relevanter Normen und Regularien (ISO 13485, MDR/ IVDR Awareness, GMP) Praxiserfahrung mit CAPA-, FMEA- und Root-Cause-Analysis-Methoden sowie Change Control Hands-on-Erfahrung in der fachlichen Leitung und Motivation cross-funktionaler Teams Analytisches Denken und Erfahrung mit Qualitätskennzahlen Sehr gute Deutsch- und gute Englischkenntnisse in Wort und Schrift Unser Angebot: Familiäres Arbeitsumfeld: Flache Hierarchien, wertschätzendes [. .. ]
Job am 19.01.2026 bei Neuvoo gefunden
D. Med Consulting GmbH
Quality Regulatory Affairs Manager Medical devices (m/f/d)
• Hamburg
Your responsibilities: Conducting regulatory GAP analyses and overseeing the interpretation and integration of applicable global regulatory requirements for medical devices into internal processes Creating, reviewing, and maintaining high-
quality technical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] documentation in compliance with MDR, IVDR, and other relevant standards Developing and managing market access and registration strategies for active and non-active medical devices, including Software as a Medical Device (Sa MD) , with focus on regulatory compliance Establishing, maintaining, and continuously improving Quality Management Systems (QMS) according to ISO, including the preparation and maintenance of [. .. ]
Job am 19.12.2025 bei Neuvoo gefunden
Sysmex
Quality Manager (f/m/x)
• Hamburg
Jobticket Work-Life-Balance
[. .. ] our company is dedicated to providing essential products that help people worldwide on their healthcare journey. If this opportunity appeals to you, come and join us in [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] the position of Quality Manager (f/m/x) As Quality Manager for in-vitro and molecular diagnostic research and development, you will ensure that all design processes and final products meet rigorous quality and regulatory standards to guarantee the safety, reliability, and compliance of Sysmexs Diagnostic Solutions. Your responsibilities Maintain, develop and continuously improve the [. .. ] Demonstrated experience managing design controls, including verification, validation and design transfer processes Proven experience working with R D teams in product development environment Strong knowledge of ISO 13485 and EU IVDR Proven track record in implementing and maintaining ISO 13485 or similar quality standards. Strong communication and decision-making skills, with a proactive and hands-on approach. Fluent in German and English, both written and spoken. Our benefits We are an aspiring corporate group where respect and trust form the basis [. .. ]
Job am 19.11.2025 bei Neuvoo gefunden
Sysmex
Production Quality Assurance Manager (f/m/x)
• Hamburg
Jobticket Work-Life-Balance
[. .. ] company is dedicated to providing essential products that help people worldwide on their healthcare journey. If this opportunity appeals to you, come and join us in the [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] position of Production Quality Assurance Manager (f/m/x) Your responsibilities What if you could be the one ensuring that every diagnostic product leaving our facilities is safe, reliable, and fully compliant with the highest quality standards? As a Production Quality Assurance Manager (f/m/x) for in-vitro and molecular diagnostic production, you play a [. .. ] compliance. Ideally, you bring the following qualifications and strengths: A completed education or degree in molecular biology, biotechnology, medical technology, or equivalent professional experience Profound knowledge of ISO 13485 and IVDR Proven experience in implementing ISO 13485 or other relevant standards Experience in production-related topics such as hygiene management, process validation, or batch record review Dedication and diligence in Quality Management and Quality Assurance topics Strong communication skills and the ability to make consistent, professional decisions with a hands-on [. .. ]
Job am 21.10.2025 bei Neuvoo gefunden
Hanseatische Personalkontor
Manager Regulatory Affairs Quality (m/w/d)
• Brunswick, Lower Saxony
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] Vorgaben. Die Pflege und Weiterentwicklung technischer Dokumentationen für bestehende und neue Produkte zählt ebenso zu Ihren Aufgaben. Darüber hinaus stellen Sie die Einhaltung relevanter Normen (z. B. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] ISO 13485, MDR/ IVDR, FDA) sicher und treiben die Weiterentwicklung des regulatorischen Systems aktiv voran. Durch die Analyse von Qualitäts- und Risikothemen leiten Sie geeignete Maßnahmen ab und stellen deren wirksame Umsetzung sicher. Sie sorgen für aktuelle und vollständige Verfahrens- und Prozessdokumentationen und achten auf deren Übereinstimmung mit regulatorischen Vorgaben. Materialanforderungen und Produktspezifikationen behalten [. .. ] sicher. In enger Zusammenarbeit mit Entwicklung, Qualitätsmanagement und Produktmanagement stellen Sie die regulatorische Konformität der Produkte sicher und unterstützen die verantwortliche Person nach IVDR. Zudem vertreten Sie bei Bedarf den Quality Manager und übernehmen bei Eignung und Interesse interimistisch die Leitung des Quality-Teams. Profil Sie verfügen über ein abgeschlossenes Studium im naturwissenschaftlichen oder medizinisch-technischen Bereich oder eine vergleichbare Ausbildung. Mehrjährige Berufserfahrung im Bereich Regulatory Affairs, idealerweise mit Bezug zu Medizinprodukten, zeichnet Ihr Profil aus. Sie bringen fundierte Kenntnisse in der [. .. ]
Neu Job vor 5 Std. bei Jooble gefunden
bestwork personal GmbH
Qualitätsmanager m/w/d
• Regierungsbezirk Braunschweig; Niedersachsen
Homeoffice möglich Abgeschlossenes Studium
Betriebliche Altersvorsorge
[. .. ] Dokumentationen unter Berücksichtigung der lokal geltenden rechtlichen Anforderungen Pflege und Erstellung von technischen Dokumentationen für bestehende und zukünftige Medizinprodukte Weiterentwicklung sowie Sicherstellung der Einhaltung aller relevanter Normen [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] (ISO 13485, MDR/ IVDR, FDA etc. ) Durchführen von Risikoanalysen nach ISO 14971, Koordinieren von Korrektur- und Präventivmaßnahmen (CAPA) und Überwachen von allen Änderungsprozessen, sowie Implementierung von Prozessoptimierungen zur Risikominimierung Bewertung und Nachverfolgung aller Verfahrensdokumente, einschließlich Richtlinien, SOPs, Handbüchern und Arbeitsanweisungen, die zur Erfüllung der behördlichen Anforderungen benötigt werden Erstellung von Materialdeklarationen und -beschränkungen (REACH, BPA, PFAS, CMRT etc. ) Enge Zusammenarbeit mit den Abteilungen Entwicklung, Qualitätsmanagement und Produktmanagement sowie Schnittstelle zur Verantwortlichen Person nach Art. 15 IVDR Unterstützung und Vertretung des Quality Manager Das bringen Sie mit: abgeschlossenes Studium im naturwissenschaftlichen oder medizinisch-technischen Bereich alternativ eine vergleichbare Ausbildung. Berufserfahrung im Bereich Regulatory Affairs idealerweise mit Bezug zu Medizinprodukten. Fundierte Kenntnisse in der Zulassung von Medizinprodukten und In-vitro-Diagnostika (IVD) mit, insbesondere gemäß MDR, IVDR, FDA und ISO 13485. Erste Erfahrungen mit [. .. ]
Häufig gestellte Fragen
Wieviele offene Stellenangebote gibt es für Quality Manager Ivdr Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 19 offene Stellenanzeigen für Quality Manager Ivdr Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Quality Manager Ivdr Jobs?
Aktuell suchen 10 Unternehmen nach Bewerbern für Quality Manager Ivdr Jobs.
Welche Unternehmen suchen nach Bewerbern für Quality Manager Ivdr Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Quality Manager Ivdr Stellenangebote:
- Sysmex (2 Jobs)
- Flinn. ai (1 Job)
- Ketryx (1 Job)
- anvajo GmbH (1 Job)
- Sanner GmbH (1 Job)
In welchen Bundesländern werden die meisten Quality Manager Ivdr Jobs angeboten?
Die meisten Stellenanzeigen für Quality Manager Ivdr Jobs werden derzeit in Sachsen-Anhalt (3 Jobs), Hessen (3 Jobs) und Sachsen (3 Jobs) angeboten.
