Senior Clinical Post-Market Surveillance Specialist

Role & responsibilities Support the development and maintenance of Post-Market Surveillance (PMS) plans, reports, and related documentation. Collect, review, and analyze clinical, complaint, vigilance, adverse-event, and product-safety data. Identify safety signals, emerging risks, adverse trends, and gaps in clinical evidence. Conduct clinical literature searches and reviews related to product safety and performance. Support Post-Market Clinical Follow-up (PMCF) activities, reports, and Periodic Safety Update Reports (PSURs). Evaluate clinical evidence against product claims, intended use, known risks, and expected benefits. Provide clinical input to complaint investigations, adverse-event assessments, and escalation decisions. Support benefit-risk assessments and updates to Clinical Evaluation, Risk Management, labeling, and regulatory documentation. Collaborate with Clinical, Quality, Regulatory, Vigilance, Complaint Handling, Risk Management, and Engineering teams. Maintain accurate, traceable PMS records and support audits, inspections, and regulatory submissions. Prepare clinical summaries, reports, presentations, and other project deliverables within established timelines. Preferred candidate profile 10+ years of experience in Clinical Affairs, Post-Market Surveillance, Clinical Evaluation, Medical Safety, or related medical-device functions. Strong experience with medical-device PMS, clinical evaluation, complaint/vigilance data, and safety assessment. Experience with clinical literature review, clinical-data analysis, and scientific documentation. Knowledge of medical-device regulatory requirements, risk management, benefit-risk assessment, and safety-signal evaluation. Strong analytical, scientific-writing, documentation, and communication skills. Ability to work effectively across Clinical, Quality, Regulatory, Medical, and Engineering functions. #J-18808-Ljbffr Tekone It Services