Staff Specialist, Post Market Surveillance
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Monthly Salary:
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
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
Bachelors 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
$87600 - $186700 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 contractors legal duty to furnish information.Required Experience:
Staff IC
Key Skills
- Microsoft Access
- SQL
- Analysis Skills
- Microsoft Powerpoint
- Securities Law
- Data Mining
- Investment Banking
- Market Research
- Microsoft Excel
- Visual Basic
- Bloomberg
- Data Analysis Skills
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
