Associate Director, DACH

Johnson & Johnson

Associate Director leading regulatory functions in Germany, Austria, and Switzerland for DePuy Synthes. Ensuring compliance and market access of products across DACH markets.

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 EU MDR compliance and strategic regulatory guidance for product lifecycle management. Proven ability to lead cross-functional teams and drive regulatory transformation initiatives within the medical device and healthcare sectors.

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 ManagementRegulatory Change MonitoringProcess Improvement InitiativesAuthority NegotiationsMulti-Country Regulatory Experience

Soft Skills

LeadershipDecision-MakingCoachingAccountabilityPerformance Management

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

Medical DeviceHealthcareRegulated IndustriesDACH MarketsQuality System StandardsGlobal Regulatory AffairsCross-Functional CollaborationRegional Policy InitiativesMatrixed OrganizationCompliance Standards

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.