Sr. Regulatory Affairs Specialist (Hybrid - Acton, MA)

About this role

Job Summary Position Overview: 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.

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 distribution • Sales talking points, etc. • Review product packaging and labeling changes for regulatory impact, including: • US labels in English • Review of translations with certified translators • Vendor documentation, certification, and fitness for quality • Represent Regulatory Affairs on project teams and in key meetings and decision making processes regarding labeling and promotion. • Assist with pre-market and post-market filings (510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations). • Prepare submissions and reports for FDA and support other international agencies as required. Review submission decisions/content issues with manager. • Provide assistance in planning, creating, organizing and interpreting regulatory documents for submission to various regulatory agencies. • Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc. • Evaluate, communicate, and present change assessments to the organization to ensure timely implementation in support of continued compliance. Review, evaluate and approve Engineering Change Orders (ECO) especially those concerning significant changes and revisions. • Performs other duties as required.

Education and Experience: • B.S. / B.A. or equivalent combination of education and experience. Minimum Requirements: • 5+ years of regulatory medical device industry experience. • RAC Certification preferred. • Knowledge of regulatory guidelines and requirements (domestic and international).

Preferred Skills and Competencies: • Effective verbal and written communication skills • Experience with reviewing ECOs, Requirements, and Specification Documents. • Understanding of 21 CFR 820, CMDR, ISO 13485, MDD. • Team player ready to work hard on a dedicated team that has the safety of the patient as priority #1. • Ability to communicate at multiple levels of an organization. • PC skill, word processing, spreadsheet, database, specifically: Word, Excel, PowerPoint, Visio, Project. • Ability to organize and manage multiple priorities. • Ability to generate and maintain accurate records.

 Position Overview: 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.

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 distribution • Sales talking points, etc. • Review product packaging and labeling changes for regulatory impact, including: • US labels in English • Review of translations with certified translators • Vendor documentation, certification, and fitness for quality • Represent Regulatory Affairs on project teams and in key meetings and decision making processes regarding labeling and promotion. • Assist with pre-market and post-market filings (510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations). • Prepare submissions and reports for FDA and support other international agencies as required. Review submission decisions/content issues with manager. • Provide assistance in planning, creating, organizing and interpreting regulatory documents for submission to various regulatory agencies. • Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc. • Evaluate, communicate, and present change assessments to the organization to ensure timely implementation in support of continued compliance. Review, evaluate and approve Engineering Change Orders (ECO) especially those concerning significant changes and revisions. • Performs other duties as required.

Education and Experience: • B.S. / B.A. or equivalent combination of education and experience. Minimum Requirements: • 5+ years of regulatory medical device industry experie

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