Manager, EUDAMED & Data Transparency

DePuy Synthes is recruiting for a(n) Manager, EUDAMED & Data Transparency, located in West Chester, PA, Raynham, MA, Warsaw, IN, Palm Beach Gardens, FL or Leeds UK.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

West Chester, PA, Raynham, MA, Warsaw, IN, Palm Beach Gardens, FL - Requisition Number: R-071881

Leeds, UK- Requisition Number: R-073158

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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, 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.

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 (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 required 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 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 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

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 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

Other

• Language: English required; additional EU language proficiency is a plus

• Travel: Up to approximately 10%, primarily domestic with limited international travel

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 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.

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