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Draft and maintain PMCF Plans and PMCF Evaluation Reports
Support in optimizing the PMCF process (SOP/templates), as part of PMS and to keep the clinical evaluation up to date
Review and contribute to Periodic Safety Update Reports (PSURs). Ensure alignment with PMCF findings
Review and contribute to Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCPs) and State of the Art (SoA) Protocol and Report. Ensure alignment with PMCF findings
Assist in data analysis and interpretation to assess product safety and performance
Contribute to PMCF Evaluation Reports, summarizing findings and clinical relevance
Maintain documentation for audits, inspections and regulatory submissions. Prepare, assist and attend where relevant
Collaborate to address feedback from Notified Bodies and Competent Authorities
Work closely with in Clinical Research (incl. other J&J MedTech Operating Companies) and with Scientific Operations, Regulatory Affairs, Medical Affairs, Post-Market Surveillance and other departments as appropriate
Support training and awareness initiatives related to PMCF to optimize collaboration
Requirements:
Strong writing and analytical skills
Attention to detail
Connecting the dots across different sources and cross-functional inputs
Preferred Experience: Medical Devices
Post-Market Clinical Follow-Up (PMCF)
Familiar with Medical Device Regulation (EU) 2017/745 and MDCG 2020-6/7/8
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