Senior Regulatory Affairs Specialist (Hybrid - Acton, MA)

Insulet Corporation • Acton, MA, US • published 2026-09-22 23:43:00.305368

Description

Job Summary The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including working with Marketing, New Product Development, Manufacturing and Engineering.\&\#xa;\&\#xa; **Responsibilities:** * Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets. * Provide regulatory affairs support for all aspects of product development, product manufacturing, and/or clinical studies including pre\-market, post\-market and physician initiated studies. * Provide Regulatory support to on\-going compliance and corporate initiatives. * Partner with Marketing and Development teams to provide support to currently\-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. * Compile and submit documentation as required in support of marketing initiatives. Review marketing and sales promotional materials for regulatory impact, including: *• Promotional materials for journals and other media* * *Trade show booths, materials for distributio...

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