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 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 14155, ISO 14971, 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 (México)
🏢 Intellectt
📍 México