Job Function Regulatory Affairs Group
Job Sub Function Regulatory Affairs
Job Category People Leader
All Job Posting Locations Oberdorf, Basel-Country, Switzerland; Zuchwil, Switzerland
Job Description DePuy Synthes is recruiting for an Associate Director, DACH, located in Umkirch, Germany or Vienna, Austria or Zuchwil, Switzerland. The Associate Director, DACH, provides regulatory leadership across Germany, Austria, and Switzerland, ensuring compliance with local and regional regulatory requirements while enabling timely and sustainable market access for DePuy Synthes products. This role has a significant impact on business continuity and growth in major European markets and partners closely with commercial, quality, and global regulatory teams to manage regulatory risk, shape strategy, and support execution in a complex regulatory environment.
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.
Ensuring proactive engagement and shaping of regional policy initiatives that are 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).
Experience: 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 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.
Language: English required; German preferred.
Travel: Moderate regional travel across DACH markets.
Equal Opportunity Employer 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.
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Job Sub Function Regulatory Affairs
Job Category People Leader
All Job Posting Locations Oberdorf, Basel-Country, Switzerland; Zuchwil, Switzerland
Job Description DePuy Synthes is recruiting for an Associate Director, DACH, located in Umkirch, Germany or Vienna, Austria or Zuchwil, Switzerland. The Associate Director, DACH, provides regulatory leadership across Germany, Austria, and Switzerland, ensuring compliance with local and regional regulatory requirements while enabling timely and sustainable market access for DePuy Synthes products. This role has a significant impact on business continuity and growth in major European markets and partners closely with commercial, quality, and global regulatory teams to manage regulatory risk, shape strategy, and support execution in a complex regulatory environment.
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.
Ensuring proactive engagement and shaping of regional policy initiatives that are 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).
Experience: 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 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.
Language: English required; German preferred.
Travel: Moderate regional travel across DACH markets.
Equal Opportunity Employer 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.
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Associate Director, DACH Arbeitgeber: JOHNSON & JOHNSON
Johnson & Johnson bietet eine herausragende Arbeitsumgebung, die von einer starken Unternehmenskultur geprägt ist, die Innovation und Zusammenarbeit fördert. Als Global Head, IDAR Strategy & Business Operations haben Sie die Möglichkeit, in einem dynamischen Team zu arbeiten, das sich der Entwicklung lebensrettender Medikamente widmet, während Sie gleichzeitig von umfangreichen Weiterbildungs- und Entwicklungsmöglichkeiten profitieren. Die Standorte in Allschwil, Basel und anderen internationalen Büros bieten nicht nur eine attraktive Lebensqualität, sondern auch ein inspirierendes Umfeld, das Vielfalt und Inklusion schätzt.
