Staff Regulatory Compliance Specialist

Work Flexibility: Remote or Hybrid or Onsite

Stryker is seeking a Staff Regulatory Compliance Specialist to support post‑market regulatory activities within our Endoscopy Division. This role provides divisional leadership for regulatory compliance execution, field actions, audits, and continuous improvement initiatives across a global, regulated manufacturing environment. You will act as a process owner and subject matter expert, partnering cross‑functionally to ensure timely, compliant, and effective post‑market regulatory outcomes.

What You Will Do

• Lead divisional planning, coordination, and execution of post‑market regulatory activities, including field action assessments, commercial holds, and recalls

• Serve as divisional process owner for post‑market compliance processes, including field action assessments, execution, and commercial holds

• Guide cross‑functional teams in developing regulatory strategies, reports, and data summaries using raw data sources

• Act as a primary liaison with global regulatory agencies, including managing regulatory communications and submissions

• Provide leadership during internal and external audits, inspections, and compliance reviews, including risk mitigation and response strategy

• Author, revise, and maintain procedures and work instructions to align with evolving regulatory requirements

• Mentor and coach team members on compliant execution of post‑market activities, audits, and regulatory communications

• Drive continuous improvement initiatives by establishing metrics, monitoring key performance indicators, and identifying process efficiencies

What You Will Need

Required Qualifications

• Bachelor’s degree (B.S. or B.A.) required. Preferred to be in Science, Engineering, or a related discipline.

• Minimum 4 years of experience in a regulated manufacturing environment, with experience in Regulatory Affairs or Quality functions.

• Experience supporting post‑market regulatory activities, including adverse event reporting, complaint handling, or field actions

Preferred Qualifications

• Experience with post‑market vigilance reporting, including Medical Device Reporting or international incident reporting

• Working knowledge of quality management or regulatory systems used in regulated industries

• Direct experience interacting with regulatory agencies, including the U.S. Food and Drug Administration or global regulatory bodies

$89,300-$193,400 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

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.