Key Tasks:
PMCF Documentation
● Draft and maintain PMCF Plans and PMCF Evaluation Reports
Post Market Surveillance (PMS) and Clinical Evaluation Support
● 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 Safet
...
y 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
Data Collection & Analysis
● Assist in data analysis and interpretation to assess product safety and performance
● Contribute to PMCF Evaluation Reports, summarizing findings and clinical relevance
Regulatory Compliance
● Maintain documentation for audits, inspections and regulatory submissions. Prepare, assist and attend where relevant
● Collaborate to address feedback from Notified Bodies and Competent Authorities
Cross-Functional Collaboration
● 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
