Staff Regulatory Compliance Specialist

Stryker • Dallas, TX

1d • $89,300 - $193,400 • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees