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.

• 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.