Regulatory Affairs Specialist - Irvine, CA

Summary:
The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products.

Key Responsibilities:
Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).
Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.
Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates.
Other incidental duties assigned by Leadership.

Education and Experience:
Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
5-7 years of experience required