Associate Director, DACH

Johnson & Johnson

Associate Director leading regulatory affairs in DACH region for DePuy Synthes. Ensuring compliance with regulatory requirements while enabling market access for products.

Posted 6/28/2026full-timeUmkirch • 🇩🇪 GermanySenior💰 €110,500 - €175,375 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a strong focus on compliance with EU MDR and local regulations in Germany, Austria, and Switzerland. Proven ability to lead regulatory strategies, manage cross-functional stakeholder relationships, and drive regulatory transformation initiatives.

Highest-signal resume keywords

Regulatory Affairs LeadershipEU MDR KnowledgeRegulatory Strategy DevelopmentStakeholder ManagementRegulatory Affairs Certification (RAC)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceProduct RegistrationLifecycle ManagementRegulatory InspectionsAudit SupportRegulatory Portfolio ManagementProcess ImprovementHealth Authority InteractionRegulatory Change MonitoringMulti-Country Regulatory Experience

Soft Skills

LeadershipDecision-MakingCoachingAccountabilityPerformance Management

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

Medical DeviceHealthcareRegulated IndustriesDACH MarketsGlobal Regulatory AffairsQuality System StandardsMarket AccessRegulatory Affairs StrategyCross-Functional CollaborationRegulatory Transformation

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