We're looking for a candidate to fill this position in an
Ensures the establishment and maintenance of regulatory affairs
processes for U.S. registrations and product development,
international registrations, and post market – sustaining
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
Represents company on US trade associations and contributes to
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
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
Minimum of 5 years in an IVD or medical device
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