Post Market Surveillance Analyst (Hybrid)

Fremont, CA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 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.

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 contractors legal duty to furnish information.

Required Experience:

Work Flexibility: HybridThe 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...

Work Flexibility: Hybrid

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.

Travel Percentage: 10%

Required Experience:

Key Skills

Microsoft Access
SQL
Analysis Skills
Microsoft Powerpoint
Securities Law
Data Mining
Investment Banking
Market Research
Microsoft Excel
Visual Basic
Bloomberg
Data Analysis Skills

Apply Now

About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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