Associate Director Regulatory Affairs DACH (m/w/d)

De Puy Synthes is recruiting for a(n)

Associate Director, DACH - Regulatory Affairs - 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 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.
• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.
• Your 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

Required

• 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.

Other

• Certifications: RAC or equivalent preferred but not required.
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