Post Market Surveillance Analyst (Hybrid)

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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.