$100K - $150K*
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.
•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
Valid through: 2020-5-14