Manager, EUDAMED & Data Transparency

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Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Clinical Development & Research – Non-MD
Job Category: People Leader
Location: Leeds, West Yorkshire, United Kingdom

Job Description
DePuy Synthes is recruiting for a Manager, EUDAMED & Data Transparency, located in Leeds UK. Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes.

Job Overview
The Manager, EUDAMED & Data Transparency is responsible for leading compliance, governance, and operational execution for the EUDAMED Clinical Investigations module(s) and relevant aspects of the Notified Bodies/Certificates module(s) in support of EU MDR requirements. The role ensures accurate, timely, and inspection‑ready reporting for these EUDAMED key activities, while partnering with cross‑functional stakeholders to maintain compliant processes and data controls.

This position offers the opportunity to operate at the intersection of regulatory affairs, clinical operations, data governance, and digital enablement—supporting EU MDR transparency requirements and the company’s broader clinical trial registration/disclosure obligations, including ClinicalTrials.gov and other global clinical trial registries, as applicable.

Key Responsibilities

• Maintain a working knowledge of global regulations and guidance governing clinical trial registration and results disclosure (e.g., EUDAMED, ClinicalTrials.gov and other global registries) and develop, maintain, and improve compliant procedures, controls, and documentation.
• Lead EUDAMED submission, maintenance, and data governance activities focused on the Clinical Investigations module(s) in alignment with EU MDR requirements.
• Ensure accuracy, completeness, and timeliness of EUDAMED data elements required to support clinical investigation registration, updates, results postings, and certificate/notified body information.
• Partner with Regulatory Affairs, Clinical Research/Operations, Quality, IT, and business teams to define and implement compliant data processes.
• Monitor regulatory and policy changes impacting EUDAMED Clinical Investigations and other relevant modules and assess impacts to internal processes.
• Support health authority and notified body inspections, audits, and regulatory inquiries related to EUDAMED key activities and clinical trial registration/disclosure.
• Drive continuous improvement initiatives focused on data quality, module readiness, and operational efficiency for EUDAMED Clinical Investigations activities.
• Provide subject‑matter expertise, guidance, and training to internal stakeholders on EUDAMED requirements and global trial registry requirements.
• Provide input to related SOPs, work instructions, and templates, supporting audits and inspection readiness.
• May be assigned responsibilities related to scientific writing support, as required.

Qualifications
Education

• Bachelor’s degree required (Regulatory Affairs, Life Sciences, Engineering, Health Sciences, or related field)
• Master’s degree or advanced degree preferred

Experience and Skills
Required

• Typically requires 6–8 years of relevant experience in clinical or regulatory affairs, compliance, data governance, or related functions.
• Working knowledge of EU MDR and EUDAMED requirements.
• Requires solid knowledge of Good Clinical Practices and international regulations.
• Experience managing complex data processes and regulatory systems.
• Strong understanding of medical device regulatory frameworks and data integrity principles.
• Demonstrated ability to build collaborative relationships with key internal and external partners.
• Change agent in team development and progression.
• Advanced project management skills with ability to handle multiple projects.

Preferred

• Experience supporting EU MDR transparency obligations, including EUDAMED Clinical Investigations submissions and updates.
• Experience with clinical trial registration and results disclosure, including ClinicalTrials.gov.
• Experience with EUDAMED and/or regulatory IT systems and structured data platforms.
• Prior experience supporting audit and inspection readiness.
• Proven ability to lead cross‑functional collaboration in a matrixed organization.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.