Insulet Corporation · 5 hours ago
Principal Regulatory Affairs Specialist (Hybrid)
Acton, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$109K/yr - $164K/yr
8+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Principal Regulatory Affairs Specialist will lead strategic regulatory initiatives and projects to ensure regulatory approval and compliance of medical devices in both domestic and international markets, collaborating with various departments throughout the product lifecycle.
Health CareMedicalMedical Device
Responsibilities
Lead strategic regulatory initiatives and projects to ensure regulatory approval and compliance of medical devices in both domestic and international markets. Provide regulatory affairs expertise for 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
Compile and submit documentation as required in support of marketing initiatives
Represent Regulatory Affairs on strategy and compliance project teams in areas of expertise
Lead or support the expert review of pre-market filings as appropriate (Q-Sub, 510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations)
Lead in planning, creating, organizing and interpreting regulatory documents for strategic regulatory initiatives
Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc, as required depending on project
Performs other duties as required
Qualification
Required
B.S. / B.A. or equivalent combination of education and experience
8+ 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 Clinical Evaluation Plan/Reports
Experience with mobile medical device applications, wearables, and cloud enabled systems
Understanding of 21 CFR 820, CMDR, ISO 13485, EU MDR, IEC 62304, IEC 62366-1
Team player ready to work hard on a dedicated team
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
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