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Associate Director – Regulatory Affairs (DACH)
Johnson & Johnson MedTech · Umkirch
Stellenbeschreibung
About the role
The Associate Director, DACH will provide regulatory leadership for DePuy Synthes across Germany, Austria and Switzerland. Reporting to global regulatory affairs, you will ensure compliance with local and EU requirements while enabling timely market access for medical device products.
Key responsibilities
- Lead and execute regulatory affairs strategy for the DACH region in line with global objectives.
- Ensure compliance with country‑specific, EU, internal policy and quality system standards.
- Provide strategic guidance for product registrations, renewals, variations and lifecycle management.
- Act as the senior regulatory escalation point for DACH market support within the International QARA organization.
- Partner with Commercial, Quality, Supply Chain, Legal and Global Regulatory teams.
- Monitor regulatory changes in DACH markets and assess impact on products and operations.
- Support regulatory inspections and audits.
Required profile
- Proven regulatory affairs leadership experience in the DACH region.
- Deep knowledge of German, Austrian and Swiss medical device regulations and EU directives.
- Strong ability to work cross‑functionally with commercial, quality, supply chain and legal stakeholders.
- Excellent analytical skills to interpret regulatory changes and guide strategic decisions.
Required skills
What we offer
- Opportunity to influence regulatory strategy for a leading global medical‑device portfolio.
- Collaboration with diverse, international teams.
- Competitive compensation and benefits aligned with Johnson & Johnson standards.
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Johnson & Johnson MedTech
Umkirch
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