Staff Specialist, Post Market Surveillance na Stryker

Work Flexibility: Remote

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

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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