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Associate Director, DACH
Johnson & JohnsonAssociate Director leading regulatory affairs in DACH region for DePuy Synthes. Ensuring compliance with regulatory requirements while enabling market access for products.
About the role
Key responsibilities & impact- Provide regulatory leadership across Germany, Austria, and Switzerland, ensuring compliance with local and regional regulatory requirements while enabling timely and sustainable market access for DePuy Synthes products
- 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
Requirements
What you’ll need- Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required)
- Advanced degree or professional certification in Regulatory Affairs (preferred)
- 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
- Experience supporting global or regional regulatory operating models (preferred)
- Experience working in multinational medical device or healthcare organizations (preferred)
- Exposure to regulatory inspections, audits, and authority negotiations (preferred)
- Demonstrated success driving regulatory transformation or process improvement initiatives (preferred)
- Regulatory Affairs Certification (RAC) or equivalent (preferred)
- Strong leadership, stakeholder management, and decision‑making skills
Benefits
Comp & perks- an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions
- vacation days
- parental leave for a minimum of 12 weeks
- bereavement leave
- caregiver leave
- volunteer leave
- well-being reimbursement
- programs for financial, physical and mental health
- service anniversary and recognition awards
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 ComplianceProduct RegistrationLifecycle ManagementRegulatory InspectionsAudit SupportRegulatory Portfolio ManagementProcess ImprovementHealth Authority InteractionRegulatory Change MonitoringMulti-Country Regulatory Experience
Soft Skills
LeadershipDecision-MakingCoachingAccountabilityPerformance Management
Certifications
Regulatory Affairs Certification (RAC)