Senior Regulatory Affairs Specialist (Hybrid - Acton, MA)

Location: Hybrid, with on-site work required at an hirify.global office in Acton, Massachusetts, United States

Annual base salary: $91,700–$137,525 for U.S.-based positions

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other wearable drug-delivery technologies for people with diabetes and other conditions.

What you will do

• Support regulatory approvals and registrations for medical devices in domestic and international markets.
• Provide regulatory support across product development, manufacturing, clinical studies, and post-market activities.
• Prepare and submit documentation for FDA and international regulatory agencies, including 510(k), IDE, PMA, CE Marking, Canadian, EU, and other registrations.
• Review labeling, packaging, translations, promotional materials, sales materials, and marketing initiatives for regulatory impact.
• Review project documentation, specifications, protocols, reports, validations, and Engineering Change Orders.
• Present change assessments and represent Regulatory Affairs in project teams, meetings, and decision-making processes.

Requirements

• Bachelor’s degree or an equivalent combination of education and experience.
• 5+ years of regulatory experience in the medical device industry.
• Knowledge of domestic and international regulatory guidelines and requirements.
• Experience reviewing Engineering Change Orders, requirements, and specification documents.
• Understanding of 21 CFR 820, CMDR, ISO 13485, and MDD.
• Ability to work in a hybrid arrangement requiring on-site presence at the Acton, Massachusetts office.

Nice to have

• RAC certification.
• Experience with Word, Excel, PowerPoint, Visio, and Project.

Culture & Benefits

• Patient safety is the primary focus.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Potential eligibility for incentive compensation.