Manager, Regulatory Affairs DACH (m/f/d)

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Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category: Professional
All Job Posting Locations: Umkirch, Germany

Job

Description: Interne Stellenausschreibung vom 20.08.2026 - 02.09.2026
De Puy Synthes is recruiting for a(n) Manager, Regulatory Affairs DACH in Umkirch, Germany.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as De Puy Synthes.

The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of De Puy Synthes and your employment would be governed by De Puy Synthes employment processes, programs, policies, and benefit plans.

In that case, details of any planned changes would be provided to you by De Puy Synthes at an appropriate time and subject to any necessary consultation processes.

Job Overview

The Manager, Regulatory Affairs DACH, is responsible for leading regulatory affairs support for Switzerland within the DACH region, ensuring compliance with local regulatory requirements and enabling timely market access.

This role plays a key part in managing regulatory risk, supporting product lifecycle activities, and partnering with local, regional, and global stakeholders to support business continuity and growth.

The position offers the opportunity to work at the intersection of global strategy and local execution in a highly regulated environment.

Key Responsibilities

• Lead and manage regulatory affairs activities to support product registration, renewals, and lifecycle management for Switzerland.
• Ensure compliance with Swiss and applicable regional regulatory requirements, internal policies, and quality system standards.
• Serve as the primary regulatory point of contact for Switzerland within the DACH framework.
• Coordinate regulatory submissions, variations, renewals, and responses to health authority inquiries.
• Partner with cross‑functional teams including Quality, Supply Chain, Commercial, and Global Regulatory Affairs.
• Monitor regulatory changes and assess potential impacts to products and business operations.
• Support regulatory audits, inspections, and assessments as required.
• Contribute to continuous improvement initiatives to enhance regulatory efficiency, compliance, and consistency.
• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required).
• Advanced degree or professional certification in Regulatory Affairs (preferred).

Experience and Skills

Required

• Typically around 8 years of progressive experience in Regulatory Affairs within the medical device, healthcare, or other regulated industries.
• Strong knowledge of German, Swiss and EU regulatory requirements.
• Experience managing product registrations and lifecycle activities.
• Ability to interpret regulatory requirements and apply them to business and product decisions.
• Strong stakeholder management, communication, and collaboration skills, leadership experience.
• Ability to manage multiple priorities in a complex, fast‑paced environment.

Preferred

• Experience supporting global or multi‑country market portfolios.
• Experience working in a multinational or matrixed organization.
• Exposure to regulatory audits, inspections, or health authority interactions.
• Familiarity with EU MDR and related regulatory frameworks.
• Demonstrated experience driving regulatory or process improvement initiatives.

Other

• Language: English and German required.
• Travel: Limited; occasional regional travel within DACH.
• Certifications: RAC or equivalent preferred but not required.
• Required Skills
• Analytical Reasoning
• Business Writing
• Coaching
• Compliance Risk
• Fact-Based Decision Making
• Industry Analysis
• Legal Support
• Process Improvements
• Product Licensing
• Public Policies
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Risk Assessments
• Strategic Thinking
• Technical Credibility
• Preferred Skills
• Analytical Reasoning
• Business Writing
• Coaching
• Compliance Risk
• Fact-Based Decision Making
• Industry Analysis
• Legal Support
• Process Improvements
• Product Licensing
• Public Policies
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Risk Assessments
• Strategic Thinking
• Technical Credibility
• The anticipated base pay range for this position is: €93.500,00 - €149.845,00

Benefits

• 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.
• Insurance plans for employees and some location’s eligible dependents.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Johnson & Johnson is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.

If you are an individual with a disability and would like to request an accommodation.

Sollten Sie im Rahmen Ihrer Bewerbung die Einbeziehung bzw.

Unterstützung der Schwerbehinderten-Vertretung wünschen, so informieren Sie uns bei der ersten Kontaktaufnahme durch unser Talent Acquisition-Team – vielen Dank.

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