Senior Manager, Post Market Surveillance
Core
Oversees Post Market Surveillance (PMS) documentation, health hazard evaluations, and field corrective action/recall processes to ensure compliance with global medical device regulations and patient safety.
Role type
Senior Manager, Post Market Surveillance
Builds
Compliant quality management sub-systems and regulatory reporting for medical devices
Domain
Medical Devices / Regulatory Quality Assurance
Deliverable
client delivery
Required skills
PMS documentation management, Health Hazard Evaluation (HHE), Field Corrective Action (FCA), team leadership, regulatory compliance (FDA/MDR/ISO 13485), risk management (ISO 14971), data analysis and reporting, audit preparation
Preferred skills
Lean and Six-Sigma process improvement, clinical professional background (RN/LNP), ASQ CQE/CBA certification, Regulatory Affairs Certification (RAC)
Technologies
Pilgrim, Oracle, spreadsheets, database software
Responsibilities
Manage and supervise PMS personnel; design and maintain compliant quality management sub-systems; develop and measure key performance metrics; evaluate returned medical devices for compliance and risk; maintain PMS, HHE, and FCA reporting systems; coordinate with regulatory bodies and cross-functional stakeholders; prepare for FDA and Notified Body audits; drive continuous improvement initiatives based on surveillance findings
Seniority
Senior, hands-on IC with leadership responsibilities