Senior Regulatory Specialist (Medical Devices)

Location: Marlborough, Massachusetts, USA; hybrid with 3 days onsite each week

Salary: $88,743–$110,929 annual base pay in Massachusetts, plus bonus

Company

hirify.global is a global consumer products company with brands in beauty, wellness, personal care, and household products.

What you will do

• Coordinate regulatory guidance and filings for medical devices, wellness devices, wearables, and mobile applications worldwide.
• Manage regulatory reviews of labeling, advertising, promotional, scientific materials, and publications for marketed products.
• Support product development and post-marketing activities to meet US, Canadian, and Latin American government requirements.
• Maintain permits, licenses, registrations, labeling, and other compliance documentation for product imports and distribution.
• Review Engineering Change Requests and assess whether product changes are significant.
• Compile and submit traditional and special 510(k) submissions to the FDA, maintain ISO compliance, and serve as a contact for regulatory agencies.

Requirements

• Bachelor’s degree in a relevant field.
• 4+ years of experience in medical device regulatory affairs.
• Understanding of ISO 13485 and ISO 9001 quality management requirements.
• Ability to interpret regulatory standards and communicate with external agencies, including the FDA.
• Strong attention to detail, written and verbal communication, and ability to manage multiple projects.
• Must be authorized to work full time in the United States.

Nice to have

• Regulatory Affairs Certification for Medical Devices.

Culture & Benefits

• Hybrid schedule with onsite collaboration Tuesday through Thursday and remote work generally available Monday and Friday.
• Healthcare, dental, and vision coverage.
• Paid holidays, paid time off, and paid parental leave.
• 401(k) with company match, life insurance, and short- and long-term disability coverage.
• Paid charitable leave and educational assistance.