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Regulatory Affairs Sr. Manager - Device in Thousand Oaks, CA



$100K - $150K*


Life Sciences


8 - 10 years

Job Description

The Regulatory Affairs – Device Team builds and leverages device and combination product GRAAS capabilities to continuously meet business objectives and compliance needs. This role establishes sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement regulatory strategies and processes for medical devices (e.g., drug delivery devices, in-vitro diagnostics, software) and combination products.

Key Activities:

•Develop, implement, communicate, and maintain global regulatory strategies and plans

•Lead and/or support global filing activities and associated Health Agency meetings, including team reviews prior to submission

•Review and approve device design control deliverables, as applicable per internal policies and procedures

•Review standards and guidance for applicability; assist in establishing Amgen regulatory positions and communicating these to relevant stakeholders

•Perform change management as

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Valid through: 2020-5-14

About Amgen

Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. Located in the Conejo Valley, Amgen is the worlds largest independent biotechnology firm. In 2013, the companys largest selling product lines were Neulasta/Neupogen, two closely related drugs used to prevent infections in patients undergoing cancer chemotherapy; and Enbrel, a tumor necrosis factor blocker used in the treatment of rheumatoid arthritis and other autoimmune diseases. Other products include Epogen, Aranesp, Sensipar/Mimpara, Nplate, Vectibix, Prolia and XGEVA.
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* Ladders Estimates