Post Market Surveillance Analyst (Hybrid)

Fremont, CA

Full-time

Hybrid

New Grad, Entry Level

Stryker is a company that offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine to improve patient and healthcare outcomes. The Post Market Surveillance Analyst plays a key role in supporting post-market surveillance activities and ensuring compliance with relevant standards while processing customer complaints and regulatory reporting for the Neurovascular Division.

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Responsibilities

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

Qualification

Required

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

Preferred

Demonstrates evaluation, originality, or ingenuity in work
Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization
Seeks out diverse ideas, opinions, and insights, and applies them in the workplace