Clinical PMS Specialist

Role & responsibilities:

• Support the development, execution, and maintenance of Post-Market Surveillance plans and activities.
• Collect, review, and analyze clinical, safety, performance, complaint, vigilance, and field data.
• Evaluate complaints, adverse events, clinical trends, and other post-market information for potential safety signals.
• Conduct literature searches and assess published clinical evidence related to product safety and performance.
• Support the preparation and maintenance of Post-Market Clinical Follow-up (PMCF) plans and reports.
• Support preparation of Periodic Safety Update Reports (PSURs) and other PMS deliverables.
• Evaluate clinical evidence against product claims, intended use, known risks, and expected benefits.
• Identify emerging risks, safety trends, evidence gaps, and potential escalation concerns.
• Support benefit-risk assessments and updates to clinical evaluation and risk-management documentation.
• Provide clinical input to complaint investigations, potential adverse-event assessments, and escalation decisions.
• Support updates to Clinical Evaluation Reports, risk-management files, labeling, and regulatory documentation.
• Partner with Quality, Regulatory Affairs, Clinical Affairs, Complaint Handling, Vigilance, Risk Management, and Product Engineering teams.
• Maintain accurate, complete, and traceable PMS documentation in accordance with internal procedures.
• Support regulatory submissions, audits, inspections, and responses related to post-market clinical activities.
• Prepare clinical summaries, reports, presentations, and project updates for stakeholders.
• Complete assigned PMS and clinical-remediation activities within established timelines.

Preferred candidate profile

• 10+ years of experience in Clinical Affairs, Post-Market Surveillance, Clinical Evaluation, Medical Safety, or a related medical-device function.
• Proven experience supporting PMS activities within the medical-device industry.
• Experience reviewing clinical, complaint, vigilance, adverse-event, or product-safety data.
• Strong understanding of medical-device clinical evaluation and post-market regulatory requirements.
• Experience with clinical literature review, data analysis, and scientific documentation.
• Working knowledge of risk management, benefit-risk assessment, and safety-signal evaluation.
• Strong analytical, scientific-writing, documentation, and critical-thinking skills.
• Ability to identify clinical trends, potential safety concerns, and escalation risks.
• Excellent written and verbal communication skills.
• Ability to work effectively across Quality, Regulatory, Clinical, Engineering, and Medical functions.