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
  
  

Required Qualifications

What You Will Need

• 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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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