Question 1

What does a post-market surveillance specialist do?

Accepted Answer

A PMS specialist monitors medical device safety and performance after market launch. Key responsibilities include: Complaint Handling - Processing and investigating customer complaints, Vigilance Reporting - Submitting MDRs (FDA) and vigilance reports (EU) for adverse events, Trend Analysis - Identifying safety signals from complaint and feedback data, PMCF Planning - Designing post-market clinical follow-up studies for EU MDR, PSUR/PMSR - Preparing periodic safety update and summary reports, FSCA Management - Coordinating field safety corrective actions and recalls.

Question 2

What qualifications are needed for PMS jobs?

Accepted Answer

Post-market surveillance positions typically require: Education: Bachelor's in life sciences, nursing, engineering, or related field. Experience: 2-5 years for specialist, 5-10 years for manager roles. Knowledge: 21 CFR Part 803 (FDA MDR), EU MDR vigilance requirements, ISO 13485 feedback systems, MedWatch reporting. Skills: Data analysis, medical terminology, investigation techniques, regulatory writing. Valuable Experience: Clinical background, quality assurance, or complaint handling in regulated industry.

Question 3

What is the salary range for post-market surveillance jobs?

Accepted Answer

PMS salaries by experience level: Specialist (2-4 years): $70,000-$95,000, Senior Specialist (4-7 years): $90,000-$120,000, Manager (6-10 years): $115,000-$150,000, Director (10+ years): $145,000-$185,000. Companies with significant EU MDR portfolios often pay 10-15% above market. Vigilance and complaint management experience commands premium compensation.

Question 4

What's the difference between FDA MDR and EU vigilance?

Accepted Answer

FDA MDR (Medical Device Reporting): Required for deaths, serious injuries, and malfunctions that could cause harm. Reported via MedWatch within 30 days (5 days for certain events). EU Vigilance: Broader scope under EU MDR including serious incidents, field safety corrective actions (FSCA), and trend reporting. Reported to Competent Authorities and EUDAMED. Key Difference: EU MDR requires proactive trend analysis and periodic safety update reports (PSUR) for all Class IIa/IIb/III devices.

Question 5

What is PMCF and why is it important?

Accepted Answer

PMCF (Post-Market Clinical Follow-up) is an EU MDR requirement for ongoing clinical data collection after device launch. Purpose: Confirm device safety/performance throughout its lifetime, identify emerging risks, update clinical evaluation. Methods include: Real-world evidence studies, registries, surveys, literature reviews, complaint analysis. Importance: Required for all Class IIa/IIb/III devices under EU MDR. Many devices need active PMCF studies (not just passive data collection). This has created high demand for PMCF specialists and clinical affairs professionals.

Post-Market Surveillance Jobs

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