Regulatory Affairs Specialist IV

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Regulatory Affairs Specialist IV

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    Regulatory Affairs Specialist IV
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The DAVIS Companies has partnered with a leading Biomedical Manufacturing company to identify a Regulatory Affairs Specialist IV to join their growing team! This individual MUST be local to MN.

The Regulatory Affairs Specialist IV position requires a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre and post-market activities.This individual contributor will manage global regulatory initiatives, working with third parties as appropriate.

Responsibilities of the Regulatory Affairs Specialist IV:

  • Must be a collaborative facilitator, building consensus while championing global regulatory initiatives for projects.
  • Providing pre- and postmarket regulatory initiatives for immunoassay devices, ensuring the development and implementation of these advanced and aggressive regulatory strategies provide a competitive edge.
  • Author premarket submissions, including 510(k)s and PMA supplements to the U.S.
  • Working through design controls for product changes to determine when new registrations may be required due to design change.
  • Create / Manage Technical Files in compliance with IVDD and IVDR.
  • Work with international teams on establishing design dossiers for their intended market.
  • Collaborate with international Regulatory Affairs professionals to support global product registrations. 
  • Ensure sound premarket product regulatory strategies include the timely and consistent review of post-market activities; such as adverse events and recall notification, minimizing the risk of negative premarket submission actions, including agency review delays.
  • Communicate with regulatory agencies in the US, Canada, the EU and other geographic areas, as required.
  • Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively.

Education Required of the Regulatory Affairs Specialist IV:

  • A Bachelor’s degree with 9+ years of experience OR Master’s degree with 7+ years of regulatory experience, preferably in areas of life sciences, engineering, or quality assurance.
  • An advanced scientific degree is strongly preferred.

Experience Preferred: 

  • Fifteen years of relevant experience in a regulated medical device/diagnostic industry.
  • Subject matter expertise in regulatory affairs for In Vitro Diagnostics
  • Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and IVD in vitro diagnostics.
  • Experience in registration and commercialization of medical device and diagnostic products.
  • Proven leadership and managerial skills in order to build and sustain a vision for the work group.
  • Demonstrated track record of developing organizational capability. Global experience leading and/or participating on cross functional teams.
  • Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean




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