Manager, EUDAMED & Data Transparency

Manager, EUDAMED & Data TransparencyDePuy 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.Job OverviewThe 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 enablementsupporting 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 ResponsibilitiesMaintain 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 readinessMay be assigned responsibilities related to scientific writing support, as requiredQualificationsEducationBachelor's degree required (Regulatory Affairs, Life Sciences, Engineering, Health Sciences, or related field)Master's degree or advanced degree preferredExperience and SkillsRequiredTypically requires 68 years of relevant experience in clinical or regulatory affairs, compliance, data governance, or related functionsWorking knowledge of EU MDR and EUDAMED requirementsRequires solid knowledge of Good Clinical Practices and international regulationsExperience managing complex data processes and regulatory systemsStrong understanding of medical device regulatory frameworks and data integrity principlesDemonstrated 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 objectivesChange agent in team development and progressionAdvanced project management skills with ability to handle multiple projectsPreferredExperience supporting EU MDR transparency obligations, including EUDAMED Clinical Investigations submissions and updatesExperience with clinical trial registration and results disclosure, including ClinicalTrials.gov and other global clinical trial registriesExperience 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 readinessProven ability to lead cross-functional collaboration in a matrixed organizationStrong analytical, documentation, and problem-solving skillsClear and effective written and verbal communication skillsOtherLanguage: English required; additional EU language proficiency is a plusTravel: Up to approximately 10%, primarily domestic with limited international travelFor 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.