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MDR - Regulatory Affairs Spec III
Ref No.: 17-07139
Location: Mounds View, Minnesota
Start Date / End Date: 01/22/2018 to 01/21/2020
Spotlight call: Thursday at 10am central time
call in number: 1-415-655-0003 US Toll
Access code: 924 366 773

POSITION DESCRIPTION:
The Principal Regulatory Affairs Specialist is responsible for coordinating and preparing submissions related to our medical devices including clinical applications, initial product approval, changes to products and product renewals which may require direct interaction with regulatory agencies.

POSITION RESPONSIBILITIES:
• Coordinate and prepare product submissions for FDA and other major market regulatory agencies.
• Provide support to market-released products as necessary. This includes reviewing labeling, promotional materials, product/manufacturing process changes and documentation for changes requiring government approval. Assist in the preparation of periodic reports for FDA and other major market regulatory agencies as required by product status. Submission decision/content will be approved by manager.
• Develop and create regulatory strategies to ensure business goals are met.
• Interface with governmental agency on projects/products as identified by the manager. Negotiate directly with FDA at the reviewer level, as directed by the manager.
• Review advertising and promotion materials.

BASIC QUALIFICATIONS:

Education Required
• Bachelors or Masters degree
Years of Experience
• 7-10 Years with Bachelors
• 5-8 Years with Masters
• 3-6 Years with Doctorate
Specialized Knowledge Required
• None required

DESIRED/PREFERRED QUALIFICATIONS (optional)
• Computer software applications including knowledge of Microsoft Office
• Strong communication skills
• Results oriented focus
• Ability to work independently and support multiple projects
• PMA and AIMD experience