Director, Regulatory Affairs

Company: Abbott Laboratories
Location: Pomona
Posted on: September 13, 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, Other , Pomona, California