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 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 (Xico)
🏢 Intellectt
📍 Xico