Senior Regulatory Affairs Specialist (Medical Devices)

Location: US - Massachusetts; hybrid arrangement with required on-site work from an hirify.global office in Acton

Annual base salary: $91,700–$137,525 USD, with potential eligibility for incentive compensation.

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other wearable subcutaneous drug-delivery technologies.

What you will do

• Lead regulatory registration and submission activities for domestic and international medical device markets.
• Support product development, manufacturing, clinical studies, pre-market filings, post-market filings, and ongoing compliance initiatives.
• Review product labeling, packaging, promotional materials, sales content, translations, and vendor documentation for regulatory impact.
• Prepare submissions and reports for the FDA and other international regulatory agencies, including 510(k), IDE, PMA, CE Marking, Canadian, EU, and rest-of-world registrations.
• Review and approve specifications, procedures, test protocols, validation records, reports, and other project documentation.
• Evaluate and present change assessments and review Engineering Change Orders, particularly significant changes and revisions.

Requirements

• Bachelor’s degree or 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.
• Strong written and verbal communication, organization, prioritization, and record-keeping skills; proficiency with Word, Excel, PowerPoint, Visio, and Project.

Nice to have

• Regulatory Affairs Certification (RAC).

Culture & Benefits

• Dedicated, performance-driven environment focused on patient safety and customer expectations.
• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off and employee wellness programs.