PMQS – Clinical PMS Specialist Work Schedule: Must be available to work during US EST/CST business hours Employment Type: Full-Time Job Summary The PMQS – Clinical PMS Specialist will support clinical Post-Market Surveillance activities for medical-device products. The role will collect, review, analyze, and document post-market clinical and safety information to support the ongoing evaluation of product safety, performance, benefit-risk, and regulatory compliance. The idóneo candidate will have experience in clinical evaluation, Post-Market Surveillance, complaint-data review, literature surveillance, clinical-data analysis, and medical-device regulatory requirements. Essential Duties and Responsibilities - Support the development, execution, and maintenance of Post-Market Surveillance plans. - Collect and review post-market clinical, safety, performance, complaint, and vigilance data. - Analyze product complaints, adverse events, clinical trends, and field information for potential safety signals.



- Conduct clinical-literature searches and evaluate published evidence related to product safety and performance. - Support the preparation and maintenance of Post-Market Clinical Follow-up plans and reports. - Support the preparation of Periodic Safety Update Reports and other post-market clinical documentation. - Evaluate clinical data against product claims, intended use, known risks, and expected benefits. - Identify emerging risks, safety signals, adverse trends, or gaps in available clinical evidence. - Support benefit-risk assessments and updates to clinical-evaluation and risk-management documentation. - Collaborate with Complaint Handling, Vigilance, Regulatory Affairs, Clinical Affairs, Risk Management, Quality, and Product Engineering teams. - Provide clinical input for complaint investigations, Potential Adverse Event assessments, and escalation decisions. - Support updates to Clinical Evaluation Reports, risk-management files, labeling, and regulatory documen

📌 PMQS - Clinical PMS Specialist (Ciudad de México)
🏢 Intellectt
📍 Ciudad de México