Associate Director, DACH

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Job Description

De Puy Synthes is recruiting for an Associate Director, DACH, located in Umkirch, Germany, 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 De Puy 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.
• Ensure proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.

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.
• Anticipated Base Pay Range
• €110,500.00 – €175,375.00

Benefits

• Annual bonus with set target (percentage of pay) based on performance of the previous calendar year, or sales commissions.
• Vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well‑being reimbursement, programs for financial, physical, and mental health.
• Service anniversary and recognition awards.
• Eligibility for several insurance plans, subject to plan terms and location.
• This information is for informative purposes only; amounts and actual benefits may vary by location and are subject to change.

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, please contact us via https://www. jnj. com/contact-us/careers or for internal employees, contact Ask GS to be directed to your accommodation resource.

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