Post Market Surveillance (PMS) Specialist Medical Devices (m/f/d)

Post Market Surveillance (PMS) Specialist Medical Devices will be responsible for vigilance, post-market surveillance, and post-market clinical follow-up activities, focusing on the evaluation of vigilance data, reporting adverse events, and performing recalls/FSCAs.

Requirements

• Evaluation of adverse events based on the event description and medical device investigation results
• Provision of a decision on reporting obligations based on international regulatory requirements
• Reporting of adverse events in line with country-specific requirements
• Search and evaluation of vigilance data for medical devices using country-specific databases
• Support with risk analysis and assessment of benefit-risk-ratio
• Provision of a significant input in Health-Risk Assessments
• Provision of a decision on recall/FSCA obligations based on international regulatory requirements
• Creation of recall/FSCA related documentation
• Point of contact for inquiries from authorities and vigilance related customer interactions
• Regular update of Vigilance related SOPs based on MDR requirements, guidance documents (MDCGs) and/or (international) regulatory requirements (MDSAP, ROW)
• Provision and timely update of PMS and/or PMCF documents
• Conduct literature searches and reviews in according to MDR/MEDDEV 2.7.1 rev. 4
• Strict compliance with the quality, occupational safety and environmental regulations
• Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist