Associate Director, DACH
Location: Umkirch, Germany; Vienna, Austria; Zuchwil, Switzerland. This role may be posted under different requisition numbers (R-084444 for Germany & Vienna, R-085278 for Zuchwil). Applications submitted to any or all of these postings will be considered as a single submission. Job Overview
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 position 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. 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). 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 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. Languages:
English required; German preferred. Travel:
Moderate regional travel across DACH markets. Equal Opportunity Employer
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. 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Location: Umkirch, Germany; Vienna, Austria; Zuchwil, Switzerland. This role may be posted under different requisition numbers (R-084444 for Germany & Vienna, R-085278 for Zuchwil). Applications submitted to any or all of these postings will be considered as a single submission. Job Overview
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 position 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. 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). 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 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. Languages:
English required; German preferred. Travel:
Moderate regional travel across DACH markets. Equal Opportunity Employer
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. 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Kontaktdaten:
6010-Biosense Webster Inc. Legal Entity Recruiting-Team
