Manager, EUDAMED & Data Transparency in Leeds

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us worldwide. 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.

DePuy Synthes is recruiting for a Manager, EUDAMED & Data Transparency located in West Chester, PA, Raynham, MA, Warsaw, IN, Palm Beach Gardens, FL or Leeds, UK. This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Johnson & Johnson announced plans to separate its Orthopedics business to establish a standalone orthopedics company, DePuy Synthes. The separation is anticipated to be completed within 18 to 24 months, pending regulatory approvals and other customary conditions. If hired, you will become an employee of DePuy Synthes, governed by its employment processes, programs, policies, and benefit plans.

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) to support EU MDR requirements. The role ensures accurate, timely, and inspection‑ready reporting while partnering with cross‑functional stakeholders to maintain compliant processes and data controls. This position operates 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 knowledge of global regulations 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 for clinical investigation registration, updates, results postings (where applicable), and certificate/notified body information.
• 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 affecting EUDAMED Clinical Investigations and other modules, assessing impacts on internal processes, systems, and trial registry disclosures.
• 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 and global trial registry submissions.
• Provide subject‑matter expertise, guidance, and training to internal stakeholders on EUDAMED requirements and other global registry requirements.
• Contribute to related SOPs, work instructions, and templates to support audits and inspection readiness.
• May be assigned responsibilities related to scientific writing support, as required.

Qualifications

• Bachelor’s degree required (Regulatory Affairs, Life Sciences, Engineering, Health Sciences, or related field). Master’s degree or advanced degree preferred.
• 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.
• 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 to gain alignment, set priorities, and manage deliverables.
• Change agent in team development and progression.
• Advanced project management skills with the 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 (e.g., ClinicalTrials.gov and other global registries).
• 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.
• Strong analytical, documentation, and problem‑solving skills.
• Clear and effective written and verbal communication skills.

Other

• Language: English required; additional EU language proficiency is a plus.
• Travel: Up to approximately 10%, primarily domestic with limited international travel.

Required Skills

• Clinical Data Management
• Clinical Evaluations
• Consulting
• Developing Others
• Drug Discovery Development
• Entrepreneurship
• Good Clinical Practice (GCP)
• Inclusive Leadership
• Leadership
• Medicines and Device Development and Regulation
• Operational Excellence
• Regulatory Affairs Management
• Relationship Building
• Safety‑Oriented
• Scientific Research
• Strategic Change
• Study Management
• Team Management