Post Market Surveillance Analyst
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Fremont • California • United States
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About the role
- Processes customer complaints in the company-wide complaint handling system.
- Follows methods to analyze the complaints for safety and reportability to regulatory agencies for the Neurovascular business.
- Assures post-market regulatory requirements are met (e.g., required reports, supplemental submissions, and other post-marketing commitments).
- Reviews complaints and assesses them for regulatory reporting, within defined timelines.
- Reviews and approves complaint investigations.
- Handle all necessary complaint-handling process activities.
- Submit initial and follow-up reports to Regulatory Agencies as needed, within defined timelines.
- Works with quality investigators, local teams, and customers on gathering information for reportability decisions.
- Contributes to achieving team performance metrics and goals.
- Other duties as assigned.
Requirements
- BS in Engineering, Science, or MS in Regulatory Science
- 0+ years’ experience
- Time management skills
- Strong writing and communication skills
- Coordination and execution of basic regulatory items
- Ability to coordinate and support technical and scientific regulatory activities
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory reportingcomplaint handlingpost-market regulatory requirementssafety analysisreport submissionsinvestigation reviewdata analysis
Soft skills
time managementstrong writing skillscommunication skillscoordinationexecution
Certifications
BS in EngineeringBS in ScienceMS in Regulatory Science