Manager, EUDAMED & Data Transparency

Johnson & Johnson • West Chester, PA

9d • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree (Regulatory Affairs, Life Sciences, Engineering, Health Sciences, or related field)
• 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 and stakeholders to gain alignment, setting priorities, managing deliverables, etc. to meet assigned project objectives
• Change agent in team development and progression
• Advanced project management skills with ability to handle multiple projects
• English ; additional EU language proficiency is a plus

Nice To Haves

• Master’s degree or advanced degree preferred
• Supporting EU MDR transparency obligations, including EUDAMED Clinical Investigations submissions and updates
• Experience with clinical trial registration and results disclosure, including ClinicalTrials.gov and other global clinical trial registries
• Experience with EUDAMED and/or regulatory IT systems and structured data platforms (e.g., trial registry tools, structured content management, or master data solutions)
• Prior experience supporting audit and inspection readiness
• Proven ability to lead cross-functional collaboration in a matrixed organization
• Strong analytical, documentation, and problem-solving skills
• Clear and effective written and verbal communication skills

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 (including data quality checks and record retention)
• Lead EUDAMED submission, maintenance, and data governance activities focused on the Clinical Investigations module(s) in alignment with EU MDR requirements, as well as relevant aspects of the other related module(s)
• Ensure accuracy, completeness, and timeliness of EUDAMED data elements to support clinical investigation registration, updates, results postings (where applicable), and certificate/notified body information needed to enable compliant submissions.
• Partner with Regulatory Affairs, Clinical Research/Operations, Quality, IT, and business teams to define and implement compliant data processes for EUDAMED key activities and global trial registration/disclosure.
• Monitor regulatory and policy changes impacting EUDAMED Clinical Investigations and other relevant modules and assess impacts to internal processes, systems, and global trial registry disclosures.
• Support health authority and notified body inspections, audits, and regulatory inquiries related to EUDAMED key activities and clinical trial registration/disclosure (including registry record review and evidence packages).
• Drive continuous improvement initiatives focused on data quality, module readiness, and operational efficiency for EUDAMED Clinical Investigations activities and global trial registry submissions.
• Provide subject-matter expertise, guidance, and training to internal stakeholders on EUDAMED requirements for Clinical Investigations and relevant NB/Certificates aspects and on ClinicalTrials.gov and other global trial registry requirements, as applicable.
• Provide input to related SOPs, work instructions, and templates, supporting audits and inspection readiness
• May be assigned responsibilities related to scientific writing support, as

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager