Post Market Surveillance (PMS) Specialist Medical Devices (m/f/d)
Core
Point of contact for medical/clinical issues responsible for vigilance, Post-Market surveillance (PMS), and Post-Market Clinical Follow-Up (PMCF) activities.
Role type
Post Market Surveillance (PMS) Specialist
Builds
Vigilance data evaluations, adverse event reports, recall/FSCA documentation, and regulatory compliance updates.
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Adverse event reporting, Vigilance data evaluation, Risk assessment, Regulatory requirements knowledge, Literature search, QMS knowledge
Preferred skills
Medical writing, Benefit-risk ratio analysis
Technologies
Country-specific vigilance databases
Responsibilities
Evaluate adverse events and investigation results, Report adverse events per country-specific requirements, Support risk analysis and benefit-risk-ratio assessment, Create recall/FSCA documentation, Update Vigilance SOPs based on MDR requirements, Conduct literature searches and reviews per MDR/MEDDEV guidelines
Seniority
Mid-level, hands-on IC
