Requisition ID: 23963BR Job Title: Representative, Post Market Compliance Regulatory Affairs Division: Instruments Business Unit: Shared Services Business Function: Regulatory Affairs Business Sub Function: Country: United States State: MI City: Kalamazoo Shift: 1st Job Description: Do you have a passion and a drive for quality? Do you thrive in a fast paced environment? Are you looking to be part of a motivated, highly visible team with a leader in the medical technology industry? Becoming a Senior Post Market Compliance Representative at Stryker Instruments will give you just that. In this position, you will play a significant role on our Compliance team at Instruments. Our top candidates will possess strong communications skills as well as a keen understanding of a highly regulated environment. The best applicants will also have great attention to detail and the ability to make important decisions on their own.
IN THIS ROLE YOU WILL:
- Ensure regulatory compliance by completing the appropriate filings and documentation.
- Prepare, review, analyze and file appropriate regulatory documentation (e.g. adverse event reports, additional information requests to regulated bodies).
- Make adverse event reporting decisions.
- Submit MDR and MDV reports to FDA and other competent authorities.
- Researches potential injury liability issues.
- Communicate or facilitate communication of complaint investigation to sales reps/customers.
- Provide input for and approval of risk management documentation.
- Creates filing strategies and position papers to support regulatory decisions.
- 1+ years of experience in a regulated environment
- Excellent analytical and writing skills
- Excellent interpersonal skills
- Excellent organizational skills
- Basic PC skills
- B.A. or B.S. Qualifications/Work Experience: Percent Travel Required: 10
Stryker - 7 months ago
Is this an operating room or Dad's workshop? Stryker's surgical products include such instruments as drills, saws, and even cement...