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 documentation. - Maintain complete, accurate, and traceable PMS records in accordance with internal procedures. - Support regulatory submissions, audits, inspections, and responses related to post-market clinical activities. - Prepare post-market clinical summaries, reports, presentations, and status updates for project stakeholders. - Complete assigned PMS and clinical-remediation deliverables within established timelines. Required Qualifications - 10+ years of experience in Clinical Affairs, Post-Market Surveillance, Clinical Evaluation, Medical Safety, or related medical-device functions. - Experience supporting Post-Market Surveillance activities for medical devices. - Experience reviewing clinical, complaint, vigilance, adverse-event, or product-safety data. - Knowledge of medical-device clinical-evaluation and post-market regulatory requirements. - Experience with clinical-literature review, data analysis, and scientific documentation. - Understanding of risk management, benefit-risk assessment, and safety-signal evaluation. - Strong scientific-writing, documentation, analytical, and critical-thinking skills. - Ability to identify clinical trends, safety concerns, and escalation risks. - Strong written and verbal communication skills. - Ability to work with cross-functional Quality, Regulatory, Clinical, Engineering, and Medical teams. Preferred Qualifications - Experience preparing Post-Market Surveillance reports, Post-Market Clinical Follow-up documentation, or Periodic Safety Update Reports. - Familiarity with EU MDR clinical and post-market requirements. - Knowledge of ISO *****, ISO *****, and applicable medical-device vigilance requirements. - Experience supporting remediation, regulatory inspections, or retrospective clinical reviews. - Experience working with implantable, active, software-enabled, or high-risk medical devices.

📌 Pmqs - Clinical Pms Specialist (Xico)
🏢 Intellectt
📍 Xico