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

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 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. NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $91,700.00 - $137,525.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. ( Know Your Rights )