Nathan Napierski
Sr Manager, Qms Compliance & Corporate Governance @Hydrafacial
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WORK HISTORY
Sr Manager, Qms Compliance & Corporate Governance @Hydrafacial
Long Beach, CA, US
Lead global QMS compliance and corporate governance across medical device and aesthetic portfolios, aligning quality systems with regulatory and business objectives. Own enterprise governance for design controls, CAPA, nonconformance, validation, document control, change management, complaints, and post-market surveillance. Develop 2–5 year compliance roadmaps supporting 510(k) strategy, EU MDR portfolio expansion, and lifecycle planning across Class I–IIa devices. Partner cross-functionally to assess regulatory impact of product and process changes, support submission readiness, and drive risk-based decision-making. Lead audit readiness and external inspections against ISO 13485, MDSAP, EU MDR 2017/745, FDA 21 CFR 820, and Korea CGMP, including support for an ISO 13485 surveillance audit with zero findings. Established company QMS and corporate governance KPIs with automated Power BI and Snowflake dashboards to improve executive visibility, management review, and compliance performance.
EDUCATION
University of Arizona
Bachelor of Science - BS, Biochemistry and Molecular and Cellular Biology
SKILLS
ABOUT NATHAN NAPIERSKI
I’m a regulatory affairs, quality systems, and compliance leader with experience building compliant, scalable frameworks across medical devices, IVD, and regulated product environments. I lead QMS compliance, corporate governance, and cross-functional programs that turn regulatory requirements into practical business systems supporting market access, product lifecycle management, and operational execution.My work spans 510(k) strategy and submission readiness, EU MDR portfolio expansion, ISO 13485, FDA 21 CFR 820, MDSAP, design controls, CAPA, validation, technical documentation, risk management, change control, complaints, and post-market processes. I partner closely with Regulatory Affairs, R&D, Operations, Manufacturing, and Supply Chain to evaluate regulatory impact, strengthen audit readiness, and build scalable processes that support growth.In my current role, I develop 2–5 year compliance roadmaps, establish enterprise QMS and corporate governance KPIs, and build automated dashboards that give leadership better visibility into CAPA effectiveness, complaint trends, deviations, audit actions, and management review metrics. I’ve also supported successful audit outcomes, including ISO 13485 surveillance activities with zero findings, while driving remediation, validation frameworks, and technical documentation readiness.Earlier in my career, I led process engineering in high-volume medical device manufacturing, supported commercialization of PCR and antigen test kits, and built a strong scientific foundation through molecular and cardiac research, including a first-author peer-reviewed publication.I’m especially energized by roles where regulatory strategy, quality systems, and business execution come together—and where compliance can be used as a lever for speed, scale, and market access.
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