Work Flexibility: Remote or Hybrid or Onsite

Stryker is hiring a Specialist, Post Market Quality for our Instruments division in Portage, Michigan. As a Post Market Specialist, you will evaluate incoming product complaints to determine compliance with MDR and/or MIR reporting requirements. For reportable events, you will ensure well-written reports are submitted to regulatory agencies within required timeframes. For non-reportable events, you will analyze risk data and collaborate with clinicians or subject matter experts to provide a thorough justification for non-reporting.

 

Workplace flexibility: The ideal candidate would reside within a commutable distance to Portage, Michigan, as regular onsite presence at the facility is highly valuable. While most of the team operates fully remotely, a hybrid work arrangement is preferred to ensure periodic onsite engagement.

 

What you will do

• Address inquiries from global Regulatory Agencies and support regulatory audits.

• Review and close complaints, ensuring accurate classification and comprehensive documentation.

• Conduct adverse event filings (e.g., MDR/MDV) and respond to Additional Information requests.

• Investigate product failures, assess risks, and identify trends to improve post-market surveillance.

• Collaborate on product recalls, including recall communications and nonconforming product quarantine.

• Research labeling, literature, and injury liability issues to mitigate regulatory exposure.

• Lead or participate in cross-functional projects to enhance processes and ensure compliance.

• Monitor evolving regulations, update SOPs, and maintain compliance with regulatory requirements.

 

What you need

Required:

• Bachelor’s degree with no prior work experience needed.

Preferred:

• Proven experience in regulated industries, with a strong preference for the medical device sector.

• Expertise in post-market quality processes, including complaint investigation and regulatory reporting.

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.