Staff Regulatory Compliance Specialist

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.

Posted Date: 04/15/2026
This role will be posted for a minimum of 3 days.