Job details
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.
