Manager, EUDAMED &UDI

Johnson & Johnson MedTech; Zuchwil; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

Johnson & Johnson is recruiting a Manager, EUDAMED & UDI located in Zuchwil, Switzerland. The Manager, EUDAMED & UDI, Regulatory is responsible for leading and coordinating regulatory activities related to EUDAMED and Unique Device Identification (UDI) compliance.

This role drives accurate, timely regulatory data submissions in line with EU MDR requirements and partners with Regulatory Affairs, Quality, IT, and business stakeholders to support product lifecycle management and market

Qualifikationen

• Typically 6-8 years of progressive experience in Regulatory Affairs or regulatory data management.
• Strong knowledge of EU MDR, EUDAMED, and UDI regulatory requirements.
• Experience coordinating regulatory data submissions and maintaining compliance records.
• Ability to interpret regulatory requirements and translate them into operational processes.
• Effective stakeholder management and communication skills.

Aufgaben

• Lead EUDAMED and UDI regulatory activities, ensuring compliance with EU MDR and related regulatory requirements.
• Coordinate preparation, review, and submission of EUDAMED data, including actor, device, and vigilance-related information.
• Provide regulatory guidance and oversight for UDI implementation, maintenance, and data governance.
• Partner with cross-functional teams (Regulatory Affairs, Quality, IT, Supply Chain) to ensure data accuracy, consistency, and traceability.
• Monitor changes to EU MDR, EUDAMED, and UDI requirements and assess impacts to products and processes.
• Support internal and external audits, inspections, and regulatory assessments related to EUDAMED and UDI compliance.
• Develop and maintain internal procedures, guidance, and training related to EUDAMED and UDI processes.
• Drive continuous improvement initiatives to enhance regulatory data quality, efficiency, and compliance.

Kenntnisse

EU MDR knowledge

UDI regulatory expertise

Stakeholder management

Regulatory data management

Ausbildung

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or related

Advanced degree or professional certification in Regulatory Affairs (preferred)

Tools

RIM (Regulatory Information Management)

Jobbeschreibung

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Job Sub Function

Job Category

All Job Posting Locations

Zuchwil, Switzerland

Job Description

DePuy Synthes is recruiting for a Manager, EUDAMED &UDI located in Zuchwil, Switzerland.

The Manager, EUDAMED & UDI, Regulatory is responsible for leading and coordinating regulatory activities related to EUDAMED and Unique Device Identification (UDI) compliance. This role plays a critical part in ensuring accurate, timely, and compliant regulatory data submissions in line with EU MDR requirements. The position partners closely with Regulatory Affairs, Quality, IT, and business stakeholders to support product lifecycle management, regulatory readiness, and sustained market access across Europe.

Key Responsibilities

• Lead EUDAMED and UDI regulatory activities, ensuring compliance with EU MDR and related regulatory requirements.
• Coordinate preparation, review, and submission of EUDAMED data, including actor, device, and vigilance‑related information.
• Provide regulatory guidance and oversight for UDI implementation, maintenance, and data governance.
• Partner with cross‑functional teams (Regulatory Affairs, Quality, IT, Supply Chain) to ensure data accuracy, consistency, and traceability.
• Monitor changes to EU MDR, EUDAMED, and UDI requirements and assess impacts to products and processes.
• Support internal and external audits, inspections, and regulatory assessments related to EUDAMED and UDI compliance.
• Develop and maintain internal procedures, guidance, and training related to EUDAMED and UDI processes.
• Drive continuous improvement initiatives to enhance regulatory data quality, efficiency, and compliance.

Qualifications

Education:

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

Required

Experience and Skills:

• Typically 6-8 years of progressive experience in Regulatory Affairs or regulatory data management within a regulated industry.
• Strong knowledge of EU MDR, EUDAMED, and UDI regulatory requirements.
• Experience coordinating regulatory data submissions and maintaining compliance records.
• Ability to interpret regulatory requirements and translate them into operational processes.
• Effective stakeholder management and communication skills.

Preferred

• Experience in the medical device or healthcare industry.
• Exposure to regulatory inspections, audits, or notified body interactions.
• Experience working in a global or matrixed organization.
• Familiarity with regulatory information management systems (RIM).
• Demonstrated experience driving regulatory process or data governance improvements.
• Strong attention to detail and ability to manage complex data sets.

Other

• Language: English required; additional European languages preferred.
• Travel: Limited; occasional international travel as required.
• Certifications: RAC or equivalent preferred but not required.
• For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy 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 DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#DePuySynthesCareers

Required Skills

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