Staff Specialist, Post Market Surveillance

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

Preferred

$87,600 - $186,700 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Health benefits include : Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include : Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M / F / Veteran / Disability.