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Lead compliance, governance, and operational execution for EUDAMED Clinical Investigations and Notified Bodies modules to support EU MDR requirements. Partner with cross-functional stakeholders to ensure accurate, timely, and inspection-ready reporting for clinical trial registrations and disclosures.
Requires a Bachelor's degree in Regulatory Affairs, Life Sciences, or a related field with 6-8 years of experience in clinical or regulatory affairs. Must have working knowledge of EU MDR, EUDAMED, and Good Clinical Practices.
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. 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:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Clinical Development & Research – Non-MDDePuy 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.
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At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
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