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.

What you will do

• 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.

What you need

• 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.