Insulet Corporation Manager, Regulatory Affairs - Advertising, Labeling, and Promotion in Billerica, Massachusetts
This position will support the Insulet Commercial, Regulatory, Clinical and Medical teams in the labeling, promotion, and clinical publication of marketed products. This will include review of materials, articles, studies, and documents related to Insulet’s medical devices and claims and ensuring that compliance to applicable labeling and promotion regulations are maintained.
Establish and maintain procedures for advertising, labeling, promotion, and clinical publications.
Lead Regulatory and Quality efforts for advertising, labeling, promotion, and clinical publications.
Train commercial functions, sales reps, patient trainers, patient advocate speakers, and Global Commercial on compliance with advertising, labeling, promotion, and clinical publication statues.
Serve as Regulatory lead in promotional review for HCP and Patient advertising and promotion, supporting Marketing and Sales.
Provide daily guidance to Commercial groups on effective and compliant promotion of Insulet products.
Review, comment, approve, and provide documented evidence of approval of promotional materials.
Develop, manage, and update procedures for generation, review, approval, and documentation of labeling, promotions, and clinical publications based upon product claims.
Attend team meetings to discuss current and future promotion endeavors, and assist in development of materials that are compliant.
Provide leadership in joint team meetings and ensure regulatory compliance and quality assurance requirements are met and documented.
BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience. Master’s degree preferred.
Experience managing staff.
A minimum of 7 years work experience in Regulatory Affairs within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience
Experience in the development, management, and documentation of labeling and promotional materials in a regulated environment.
Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
Working knowledge of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint).
Demonstrated experience organizing and maintaining large documentation sets.
Ability to follow up with task owners to close out open items.
Effective verbal and written communication skills.
Experience collaborating and communicate with individuals at multiple levels in an organization.
Ability to organize and judge priorities.
Ability to generate and maintain accurate records.
Skilled in computer use including word processing, spreadsheet, and database applications.
Able to work effectively in a high-stress, high-energy environment.
External Company Name: Insulet Corporation
External Company URL: http://www.myomnipod.com/