DePuy Synthes is recruiting for an Associate Director, DACH, located in Umkirch, Germany or Vienna, Austria or Zuchwil, Switzerland.
Positions are available with the following requisition numbers: Amazon on information for specific countries:
Umkirch, Germany & Vienna, Austria: R‑084444 ;
Zuchwil, Switzerland: R‑085278 . Applications submitted for any or all of these postings will be considered as a single submission.
Key Responsibilities
Lead and oversee regulatory affairs strategy and execution across DACH local markets in alignment with global regulatory objectives.
Ensure compliance with country‑specific and EU regulatory requirements, internal policies, and quality system standards.
Provide strategic regulatory guidance to support product registrations, renewals, variations, and lifecycle management.
Serve as the senior regulatory escalation point for DACH Local Market Support within the International QARA organization.
Partner with cross‑functional stakeholders including Commercial, Quality, Supply Chain, Legal, and Global Regulatory Affairs.
Monitor regulatory changes across DACH markets and assess potential impacts to products, portfolios, and operations.
Support regulatory inspections, audits, and health authority interactions as required.
Lead, coach, and develop regulatory talent, fostering strong compliance, accountability, and performance.
Ensure proactive engagement and shape regional policy initiatives critical to business strategy, continuity, and growth.
Qualifications Education
Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required).
Advanced degree or professional certification in Regulatory Affairs (preferred).
Required Experience and Skills
Typically 8–10 years of progressive experience in Regulatory Affairs within the medical device, healthcare, or other regulated industries.
Strong knowledge of EU MDR and regulatory requirements across Germany, Austria, and Switzerland.
Demonstrated experience leading multi‑country or regional regulatory portfolios.
Proven ability to develop and execute regulatory strategies aligned to business objectives.
Ability to operate effectively in a global, matrixed organization.
Preferred Experience and Skills
Experience supporting global or regional regulatory operating models.
Experience working in multinational medical device or healthcare organizations.
Exposure to regulatory inspections, audits, and authority negotiations.
Demonstrated success driving regulatory transformation or process improvement initiatives.
Regulatory Affairs Certification (RAC) or equivalent.
Strong leadership, stakeholder management, and decision‑making skills.
Additional Requirements
Language: English required; German preferred.
Travel: Moderate regional travel across DACH markets.
Certifications: RAC or equivalent preferred but not required.
Equal Opportunity Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Inclusive Interview Process Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us at https://www.jnj.com/contact-us/careers.
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Positions are available with the following requisition numbers: Amazon on information for specific countries:
Umkirch, Germany & Vienna, Austria: R‑084444 ;
Zuchwil, Switzerland: R‑085278 . Applications submitted for any or all of these postings will be considered as a single submission.
Key Responsibilities
Lead and oversee regulatory affairs strategy and execution across DACH local markets in alignment with global regulatory objectives.
Ensure compliance with country‑specific and EU regulatory requirements, internal policies, and quality system standards.
Provide strategic regulatory guidance to support product registrations, renewals, variations, and lifecycle management.
Serve as the senior regulatory escalation point for DACH Local Market Support within the International QARA organization.
Partner with cross‑functional stakeholders including Commercial, Quality, Supply Chain, Legal, and Global Regulatory Affairs.
Monitor regulatory changes across DACH markets and assess potential impacts to products, portfolios, and operations.
Support regulatory inspections, audits, and health authority interactions as required.
Lead, coach, and develop regulatory talent, fostering strong compliance, accountability, and performance.
Ensure proactive engagement and shape regional policy initiatives critical to business strategy, continuity, and growth.
Qualifications Education
Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required).
Advanced degree or professional certification in Regulatory Affairs (preferred).
Required Experience and Skills
Typically 8–10 years of progressive experience in Regulatory Affairs within the medical device, healthcare, or other regulated industries.
Strong knowledge of EU MDR and regulatory requirements across Germany, Austria, and Switzerland.
Demonstrated experience leading multi‑country or regional regulatory portfolios.
Proven ability to develop and execute regulatory strategies aligned to business objectives.
Ability to operate effectively in a global, matrixed organization.
Preferred Experience and Skills
Experience supporting global or regional regulatory operating models.
Experience working in multinational medical device or healthcare organizations.
Exposure to regulatory inspections, audits, and authority negotiations.
Demonstrated success driving regulatory transformation or process improvement initiatives.
Regulatory Affairs Certification (RAC) or equivalent.
Strong leadership, stakeholder management, and decision‑making skills.
Additional Requirements
Language: English required; German preferred.
Travel: Moderate regional travel across DACH markets.
Certifications: RAC or equivalent preferred but not required.
Equal Opportunity Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Inclusive Interview Process Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us at https://www.jnj.com/contact-us/careers.
#J-18808-Ljbffr
Associate Director, DACH Arbeitgeber: Johnson & Johnson MedTech
Abiomed ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in der Region Nordwest- und Nordostdeutschland eine dynamische Arbeitsumgebung bietet, die auf persönliches und berufliches Wachstum ausgerichtet ist. Mit einem starken Fokus auf Teamarbeit und kontinuierliche Weiterbildung fördert das Unternehmen eine Kultur des Austauschs und der Zusammenarbeit, während es gleichzeitig attraktive Vorteile wie flexible Urlaubsregelungen, Elternzeit und Gesundheitsprogramme bietet. Die Möglichkeit, an bedeutenden chirurgischen Konferenzen teilzunehmen und innovative Produkte im Bereich der mechanischen Kreislaufunterstützung zu implementieren, macht diese Position besonders lohnend und bedeutungsvoll.
Kontaktdaten:
Johnson & Johnson MedTech Recruiting-Team
