Job Summary

Sr Regulatory Affairs Specialist

  • Location:
    Plymouth, Minnesota
  • Job reference:
    US_EN_3_105992_327101
  • Category:
    Bio-Medical
  • Contract Type:
    Contract/Temporary

A Sr. Regulatory Affairs Specialist job in Plymouth, MN is available through Modis Engineering. Candidates will be responsible for providing regulatory expertise for a class II medical device company. Hands on 510(k) experience is REQUIRED for this role. Candidates will also be required to provide regulatory advice and assistance site to site.

Regulatory Affairs Specialist II job responsibilities include:
• Prepare and submit 510(k) Premarket Notifications, PMA, IDE and Design Dossier submissions as directed.
• Create and maintain Essential Requirements Checklists, CE Technical files and Declarations of Conformity for all products bearing the CE Markup.
• Prepare Annual PMA Report and associated PMA Supplements as required.
• Review and approve ECO’s for product changes and or modifications related to manufacturability and or material modifications.
• Ensure compliance to existing regulatory submissions.

QUALIFICATIONS:
• Bachelor’s degree in Science or Engineering.
• Five to Seven years of direct experience in quality/ regulatory affairs.
• Must have experience with reviewing and approving ECO’s and SOP’s.
• Previous experience in the Medical device, Pharmaceutical or Biomedical industries is a must.

If you are interested in this Sr. Regulatory Affairs Specialist job in Plymouth, MN then please click APPLY NOW. For other opportunities available at Modis Engineering go to www.modis.com. If you have questions about the position please contact Ray Sabio at 317-558-8868 or Raymond.Sabio@modis.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
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