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 adecuado 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 documentation. Maintain complet

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