Job Summary

Sr. Regulatory Affairs Specialist

  • Location:
    Plymouth , Minnesota
  • Category:
    Quality Assurance
  • Contract Type:
    Contract/Temporary
  • Job reference:
    US_EN_3_106014_321890

A Regulatory Affairs Specialist in Plymouth, MN is available through Modis Engineering. It is required for the person in this role to have an understanding of 510 (K) Premarket notification, PMA, and IDE. Individuals in this position will be responsible for supporting change orders as well as technical filing.
Regulatory Affairs Specialist job responsibilities include:
• Create and maintain Essential Requirements Checklists
• Submit 510 K’s field for remediation
• Review and approve technical literature, sales and marketing literature, and reimbursement documents
• Act as regulatory representative on new product development teams
QUALIFICATIONS:
• Bachelor’s degree (Scientific or Engineering Program)
• Working knowledge of up-to-date domestic, international, and company regulatory compliance requirements.
• Knowledge and ability to develop, review, and approve technical literature
• Ability to negotiate critical points regarding devices to the favor of corporate objectives

If you are interested in this Regulatory Affairs Specialist job in Plymouth, MN then please click APPLY NOW. For other opportunities available at Modis go to www.Modis.com. If you have questions about the position, please contact Caitlin Kruse at 612-656-1086 or Caitlin.kruse@modis.com.
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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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