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Senior Regulatory Affairs International Specialist - Critical Care

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Regulatory Affairs
Contact Name: Patricia Forrest
Email: apply directly online (see below)

Job Description (up to 200 words): 

As the Sr. RA Int’l Specialist, you will create complex regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).

- Represent 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.

- Provide 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.


Job Requirements (up to 200 words): 

- A Bachelor’s degree with 5 years of related experience is required.

- Full knowledge/understanding of global regulations relevant to medical devices

- Full knowledge and understanding of global regulatory requirements for new products or product changes.

- Good problem-solving, organizational, analytical and critical thinking skills.

- Ability to manage competing priorities in a fast paced environment.

- Works independently without close supervision.


Please apply online at: