Work Flexibility: 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 Science0+ years’ experienceTime management skillsStrong writing and communication skillsCoordination and execution of basic regulatory itemsAbility 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.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.