Manager, EUDAMED & Data Transparency

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 toestablisha standalone orthopedics companyoperatingas DePuy Synthes. The process of the planned separation isanticipatedto be completed within 18 to24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may berequired regulatory approvals and other customary conditions and approvals. Should you accept this position it isanticipatedthat following conclusion of the transaction you would be an employee of DePuySynthesand your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes atan appropriate timeand subject to any necessary consultation processes.

Job Overview

The Manager EUDAMED & Data Transparencyis responsible forleading 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 ensuresaccuratetimely andinspectionreadyreporting for these EUDAMED key activities while partnering withcrossfunctionalstakeholders tomaintaincompliant processes and data controls.

This position offers the opportunity tooperateat the intersection of regulatory affairs clinical operations data governance and digital enablementsupporting EU MDR transparency requirements and the companys broader clinical trial registration/disclosure obligations including 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 and other global registries) and developmaintain 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 elementsrequiredto 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 changesimpactingEUDAMED Clinical Investigations and other relevant modules and assess impactstointernal 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.

• Providesubjectmatterexpertise guidance and training to internal stakeholders on EUDAMED requirements for Clinical Investigations and relevant NB/Certificates aspects and on 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 asrequired

Qualifications

Education

• Bachelors degreerequired(Regulatory Affairs Life Sciences Engineering Health Sciences or related field)

• Masters degree or advanced degree preferred

Experience and Skills

Required

• Typically requires 68 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 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 leadcrossfunctionalcollaboration in a matrixed organization

• Strong analytical documentation andproblemsolvingskills

• Clear and effective written and verbal communication skills

Other

• Language: Englishrequired;additionalEU languageproficiencyis a plus

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

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