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Associate Director, DACH
Johnson & JohnsonAssociate Director leading regulatory functions in Germany, Austria, and Switzerland for DePuy Synthes. Ensuring compliance and market access of products across DACH markets.
About the role
Key responsibilities & impact- Provide regulatory leadership across Germany, Austria, and Switzerland.
- 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.
- Act 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.
- Engage in regional policy initiatives 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.
- English required; German preferred.
- Moderate regional travel across DACH markets.
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
- employees - and in some location’s eligible dependents - can participate in several insurance plans.
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 ManagementRegulatory Change MonitoringProcess Improvement InitiativesAuthority NegotiationsMulti-Country Regulatory Experience
Soft Skills
LeadershipDecision-MakingCoachingAccountabilityPerformance Management
Certifications
Regulatory Affairs Certification (RAC)