Job Summary

Regulatory Affairs Specialist II

  • Location:
    Plymouth, Minnesota
  • Job reference:
    US_EN_3_105992_325013
  • Category:
    Content/Document Management
  • Contract Type:
    Contract/Temporary


Regulatory Affairs Specialist II
Plymouth, MN


1 year contract



Responsibilities/Duties:

This will require travel from time to time to effectively carry out these duties. Prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to European notified body to support distribution and marketing objective set by divisional and corporate staff.
Ensure regulatory compliance to FDA and international regulations.
Prepare and submit 510(k) Premarket Notification, 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 Marking.


Technical Knowledge and Skills:

Bachelor's degree in Science or Engineering (or related field) from an accredited college or university. A minimum of Five to Seven years direct experience in quality/regulatory affairs (preferably in the medical device/drug or biomedical area).
Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures. Including but not limited to FDA, PMAA, IDE, 510(k) Notifications, Medical Device Directive, and European Standards.
Sound knowledge and understanding of how IDE regulated clinical studies are performed.
Knowledge and ability to review and approve ECO's and corporate SOP's.



Regulatory Affairs Specialist II
Plymouth, MN


1 year contract



Responsibilities/Duties:

This will require travel from time to time to effectively carry out these duties. Prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to European notified body to support distribution and marketing objective set by divisional and corporate staff.
Ensure regulatory compliance to FDA and international regulations.
Prepare and submit 510(k) Premarket Notification, 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 Marking.


Technical Knowledge and Skills:

Bachelor's degree in Science or Engineering (or related field) from an accredited college or university. A minimum of Five to Seven years direct experience in quality/regulatory affairs (preferably in the medical device/drug or biomedical area).
Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures. Including but not limited to FDA, PMAA, IDE, 510(k) Notifications, Medical Device Directive, and European Standards.
Sound knowledge and understanding of how IDE regulated clinical studies are performed.
Knowledge and ability to review and approve ECO's and corporate SOP's.

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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.

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