Staff Specialist, Post Market Surveillance

Stryker is seeking a Staff Specialist, Post Market Surveillance for our Medical division. This is a remote role with preference for someone located in the Central Time Zone. As the Staff Specialist, Post Market Surveillance, you will play a critical role in protecting patients and supporting innovation by driving compliance across global markets. What You Will Do • Lead post market surveillance (PMS) activities for US 510(k) and EU MDR certified medical devices, including PMCF Plans, Reports, and collaboration on clinical studies • Develop and maintain EU MDR-compliant PMS Plans and Periodic Safety Update Reports (PSURs) in partnership with Customer Quality Engineers • Support clinical evaluations for marketed devices in the EU, UK, and Australia in collaboration with Clinical Affairs • Assess and integrate product records for new medical devices, identifying gaps and implementing action plans • Manage product field actions (PFAs), including escalation meetings and execution of required actions • Review and report medical device complaints to global regulatory agencies within required timeframes • Serve as a subject matter expert during audits, focusing on PMS documentation, PFAs, and incident reporting • Train internal teams on PMS and PFA requirements to ensure ongoing compliance and readiness What You Need Required • Bachelor’s degree in science, engineering, or medical sciences • Minimum 4 years of experience in a regulated medical device environment, with focus on PMS and/or Regulatory Affairs • Experience with global regulatory reporting requirements, including FDA and EU MDR • Demonstrated experience integrating new products into existing systems Preferred • Prior engagement with regulatory agencies/notified bodies • RAPS Regulatory Compliance Certificate (RCC) • Experience with complaint handling systems such as TrackWise • Familiarity with 510(k) class II and EU MDR Class I and IIa devices $87,600 - $186,700 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Posted: November 4, 2025 This role will be posted for a minimum of 3 days.