Regulatory Affairs Specialist I

TL;DR

Regulatory Affairs Specialist I (Medical Devices): Support global regulatory compliance activities for medical devices across product portfolio with an accent on international registrations, labeling coordination, and sustaining change assessments. Focus on preparing and maintaining submissions, monitoring standards changes, and cross-functional collaboration for quality systems and product lifecycle.

Location: Boston, MA or Waltham, MA, US. Open to US based candidates. Able to work in the US without sponsorship.

Salary: $65,000–$82,000 + 5% annual bonus (US based).

Company

hirify.global provides hospitals and life science institutions with products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science, sold in more than 135 countries.

What you will do

• Lead preparation and maintenance of international registrations and renewals.
• Maintain Rimsys regulatory management system for registration and UDI records.
• Coordinate label updates and translation requests aligned with regulations.
• Perform sustaining change assessments for manufacturing, design, or documentation impacts.
• Monitor changes in standards and regulations, conduct gap analyses, and communicate to teams.
• Support regulatory requests, draft procedures, and contribute to quality objectives.

Requirements

• Bachelor's degree in technical or scientific discipline.
• US work authorization without sponsorship required.
• Excellent oral and written English communication skills.
• Strong organizational skills, attention to detail, multitasking, and deadline management.
• Team collaboration across departments in fast-paced environment.
• Able to travel domestically/internationally (<10%).

Culture & Benefits

• Health, Dental, and Vision insurance.
• 401k with company match, Paid Time Off, Life Insurance, Short/Long Term Disability.
• Health/Dependent Care FSA, Commuter Benefits, Parental/Caregiver Leave.
• Tuition Reimbursement, Wellness initiatives.