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Principal, Regulatory Affairs

Company

Terumo Neuro

Location

Aliso Viejo, United States

Type

Full-time

**13011BR**
**Title:**

Principal, Regulatory Affairs

**Job Description:**

Responsible for establishing, preparing, and leading the strategy for worldwide product approval submission activities. As a recognized expert, manage multiple large projects or processes. Responsible for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties:

+ Represent Regulatory on project teams and partner with the cross functions on the team to ensure alignment of global regulatory strategy with the team objectives.
+ Identify regulatory requirements for the markets identified and work independently in developing global regulatory strategy for assigned projects and develop approaches to solutions.
+ Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects and processes that span outside of im...

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