Regulatory Affairs Specialist Ii - Neuromodulation jobs at Boston Scientific in United States, Santa Clarita
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Job title (1)
United States
State
Santa Clarita
37 jobs found
19.04.2025
BS
Boston Scientific Regulatory Affairs Specialist II United States, California, Santa Clarita
Support the preparation of submissions (i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products. In conjunction with Clinical Research, support the preparation...
Oversee BVNA pricing and contracting initiatives, ensuring alignment with broader portfolio strategies. Develop and refine pricing models, including ASC strategies and convertible per-use target account strategies to drive market penetration....
Acts as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions...
Provide Quality Engineering support for sustaining activities and improvement projects for commercial products, with a focus on the project of process relocations within BSC sites. Support Non-Conformance Event Prevention (NCEP)...
Confirms case information is complete and supports medical necessity. Obtains additional information from the physician or patient as needed. Follows up timely on assigned tasks to ensure optimal case progression....
Define and Communicate Vision: Develop and articulate the product vision, strategy, and business model to teams, stakeholders, and external partners. Lead Discovery and Planning: Collaborate with business stakeholders to lead...
Collaborates with finance, sales leadership, marketing, IT and other sales operations functions to deliver on commercial strategies and drive a continuous improvement culture. Responsible for the administration and validation of...
Support the preparation of submissions (i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products. In conjunction with Clinical Research, support the preparation...
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