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Regulatory Affairs Specialist
Job ID:  Temporary/Consultant # Positions:  1
Location:  US-WA-Bothell Min. Exp. (Years):  2
Category:  Research & Development - Regulatory Affairs

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Overview:

This position will be working on a Temporary or Consultant basis at Medicis Technologies Corporation A Subsidiary of Medicis Pharmaceutical Corporation in Bothell, Washington.  This individual will report to the Vice President, Regulatory Affairs and Quality Systems.

 



Responsibilities:

Contingent Staff will be responsible for:

  • Support ongoing information requests to support and maintain the Canadian MDL
  • Develop submissions to the US FDA for new product filings
  • Develop marketing submissions:
    • Model 1 global regulatory submissions
    • Manages EU and ROW country registrations
  • Assists Medicis Aesthetics Canada with MDEL/PLL registration
  • Manages company activities related to the Export Reform and Enhancement Act
  • Develops non-filing justifications
  • Supports technical documentation file revisions
  • Provides pre-market clearance documentation to regulatory agencies worldwide
  • Performs all other duties as required in support of regulatory activities and departmental administration



Qualifications:
  • Bachelor's Degree required
  • 2-5 years experience in international medical device regulatory affairs
  • Microsoft Office and Adobe Acrobat

 

AA/EEO Employer

 




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