Post Market Surveillance Analyst (Hybrid)

Stryker•Fremont, CA

2d•Hybrid

About The Position

The Post Market Surveillance Analyst possesses a foundational understanding of regulatory and legal frameworks, including applicable requirements, legislation, processes, and procedures. This position plays a key role in supporting post-market surveillance activities and ensuring compliance with relevant standards. This is a Hybrid role supporting our Neurovascular Division, requiring a commutable distance to Fremont, CA.

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

Nice To Haves

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.

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.