Regulatory Affairs Coordinator in Portage, MI at Stryker Corporation

Date Posted: 1/14/2020

Job Snapshot

Job Description

  • Documentation remediation to support the European Medical Device Regulation project (EU MDR)
  • Escalate documentation gaps to project team
  • Aid in the gathering of product data, populating and routing for the EU MDR project and other tasks associated with ensuring EU MDR compliance
  • Remediation of DDR (Device Distribution Record) and RAA (Regulatory Affairs Assessment) information to ensure alignment and accuracy 
  • Update and maintain product lists for Notified Body and other regulatory bodies that contain applicable clearance/approval pathway 
  • Coordinate and request Certificate of Foreign Government requests 
  • Collaborate with cross-functional teams to manage content for Regulatory documentation
  • Clear and timely communication with Regulatory Affairs and project teams
  • Assist with product re-registrations
  •  Assistance during internal and external audits 

  • High School Diploma Required

  • 0 to 2 years relevant work experience

Work From Home: Not available

Travel Percentage: None

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.

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