Insulet Corporation · 4 days ago
Sr. Regulatory Affairs Specialist, Omnipod 5 Expansion (Hybrid - Acton, MA)
Massachusetts, United States
Full-time
Hybrid
Senior Level
$89K/yr - $134K/yr
5+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Senior Regulatory Affairs Specialist will lead regulatory activities for domestic and international submissions, ensuring compliance and supporting product development initiatives.
Health CareMedicalMedical Device
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
Qualification
Required
B.S. / B.A. or equivalent combination of education and experience
5+ years of regulatory medical device industry experience
Knowledge of regulatory guidelines and requirements (domestic and international)
Preferred
RAC Certification preferred
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
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
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.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase