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 *****, 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 (México)
🏢 Intellectt
📍 México