Director, Regulatory Affairs

Company: Abbott Laboratories
Location: Pomona
Posted on: September 4, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

• Ensures the establishment and maintenance of regulatory affairs processes for U.S. registrations and product development, international registrations, and post market - sustaining activities, including:
• Monitoring new and changing regulations and guidance and disseminating information to stakeholders.
• Identification of regulatory trends and provision of key regulatory intelligence updates on a global basis.
• Preparation of documentation for international and domestic product registrations for new and modified products.
• Evaluation of information to develop strategies and shape future regulations and guidance, as well as interact with governmental regulatory agencies, other third-party accrediting bodies, and US trade associations.
• Represents company on US trade associations and contributes to trade positions
• Provides regulatory support for diagnostic product development and commercial diagnostic products.
• Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally.
• Researches scientific and regulatory information to write, edit,and review submission documents.
  • Bachelor's degree (BS/BA) in any biological science
  • Minimum of 10 years of experience in Regulatory Affairs, US andinternational
  • Minimum of 5 years in an IVD or medical device manufacturingenvironment
  • Must be knowledgeable of federal and other regulations, e.g.QSR's, ISO 13485, CMDR, IVDR, MDR
  • International regulations experience
  • Strong knowledge of international regulations

Keywords: Abbott Laboratories, Pomona , Director, Regulatory Affairs, Executive , Pomona, California