Senior Clinical Post Market Specialist
Remote · Minnesota, United States or South Jordan, Utah, United States
Job Summary
Senior Clinical Post Market Specialist responsibilities include providing clinical SME support for Health Hazard Evaluation (HHE) reports, leading Post Market Surveillance (PMS) documentation such as PSUR and PMSR, assisting or executing Field Correction Actions (FCA) and recalls, reviewing Risk Management File contents for device hazards, maintaining PMS/HHE/FCA documentation across global sites, establishing and tracking KPIs for PMS operations, delivering SME training for evaluating returned medical device products, and coordinating communications with regulatory authorities, notified bodies, customers, and internal stakeholders. The role requires maintaining regulatory awareness (FDA and EU MDR/CE, ISO 13485, CMDR, ANVISA, TGA, JPAL/JGMP), and leveraging data management systems to support timely reporting and risk mitigation. Strong analytical, writing, and data presentation skills are essential. A minimum RN or LNP license is required, with 8+ years in the medical device industry; preferred additional post-graduate qualifications in quality management and related certifications.”,
Required Qualifications
- minimum of a registered nursing (RN) or licensed nurse practitioner (LNP) or equivalent education and experience to support regulatory determinations of potential clinical harms in support of HHE related decision making
- At least eight (8) years of work-related experience in the medical device industry
- Knowledge of U.S. FDA regulations (21 CFR 803, 806, 820), the Medical Devices Directive (93/42/EEC, as amended), the European Medical Device Regulation 2017/745 (MDR), ISO 13485 Quality System Standards, and Canadian Medical Device Regulation (CMDR), ANVISA, TGA and JPAL/JGMP
- Knowledge of ISO 14971 Risk Management related activities and requirements
- Demonstrated experience with electronic data management systems (e.g., Pilgrim, Oracle), computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs
- Excellent data, analysis, trends, and reporting skills. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and workflows
- PREFERRED QUALIFICATIONS Post graduate diploma / master’s degree in quality management. Familiarity with Lean/Six-Sigma tools. ASQ certifications CQE/CBA. RAC (Global)
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.