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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Regulatory Affairs, particularly within the medical device and healthcare sectors, with a strong focus on EU MDR compliance and strategic regulatory guidance across DACH markets. Proven leadership in managing multi-country regulatory portfolios and developing regulatory strategies that align with business objectives.
Highest-signal resume keywords
Regulatory Affairs StrategyEU MDR ComplianceMulti-Country Regulatory PortfoliosRegulatory Strategy DevelopmentRegulatory Inspections Support
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsEU MDRProduct RegistrationLifecycle ManagementRegulatory Compliance
Soft Skills
LeadershipCoachingCross-Functional Collaboration
Industry Keywords
Medical DeviceHealthcareRegulated IndustriesDACH MarketsQuality System Standards
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