Regulatory Affairs Specialist  

Overview:

This position will be working on a Temporary or Consultant basis atMedicis Technologies CorporationA Subsidiary of Medicis Pharmaceutical Corporationin Bothell, Washington. This individual will report to theVice 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
  • Developmarketingsubmissions:
    • 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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