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Associate Director, DACH
Johnson & JohnsonAssociate Director overseeing regulatory strategy and compliance for DePuy Synthes in DACH markets. Ensuring product registrations and lifecycle management in compliance with local regulations.
About the role
Key responsibilities & impact- Lead and oversee regulatory affairs strategy and execution across DACH local markets
- 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
- 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
Requirements
What you’ll need- 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
- English required; German preferred
Benefits
Comp & perks- Health insurance
- Professional development
- Equipment allowances
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory AffairsEU MDRProduct RegistrationLifecycle ManagementRegulatory Compliance
Soft Skills
LeadershipCoachingCross-Functional Collaboration