Post Market Surveillance Adverse Event Analyst
Core
Investigate customer complaints related to injury, adverse events, or death; make regulatory reporting decisions; file reports; and ensure completeness of complaint documentation.
Role type
Post Market Surveillance Adverse Event Analyst
Builds
Regulatory reports and complaint files for medical devices
Domain
Medical device regulatory compliance and post-market surveillance
Required skills
Regulatory reporting (FDA 21 CFR 803/820.198), Global regulatory requirements (EU, MDSAP), Complaint investigation, Risk classification (IMDRF codes), Root cause analysis, Data analysis for trends, Cross-functional collaboration, Documentation management
Preferred skills
Life science degree, Engineering background, Advanced English proficiency, Experience with medical device field
Technologies
Excel, Word, PowerPoint, Database query tools
Responsibilities
Investigate serious injury/adverse event/death complaints; Perform preliminary classification and reportability triage; Follow up with surgeons and healthcare professionals; Draft and file medical device and vigilance reports; Analyze complaint data to identify trends; Collaborate with engineering, medical safety, and risk management teams; Ensure compliance with post-market surveillance processes; Complete responses for Regulatory Agency Requests; Participate in internal and external audits.
Seniority
Mid-Senior level (5+ years experience)