Senior Regulatory Affairs Specialist

Job overview

The Senior Regulatory Affairs Specialist role is remote, with the listing location in Somerville, MA. Compensation is $120,000–$165,000 per year. The role supports DeepHealth’s product development and regulatory activities for commercializing digital products, including artificial intelligence technologies. The specialist provides regulatory guidance to cross-functional teams and supports submissions, product lifecycle planning, and compliance for medical and non-medical products. The work helps ensure products and related clinical activities meet applicable regulatory requirements before and after market entry.

What you'll do

• Represent Regulatory Affairs on cross-functional teams
• provide strategic and technical guidance on product lifecycle planning and regulatory requirements
• assess medical-device submission documentation
• assist with SOP development and regulatory submissions
• maintain technical documentation
• evaluate design, labeling, and distribution changes
• support post-market compliance and clinical studies
• submit adverse events to appropriate regulatory bodies
• review product labeling.

What we're looking for

Skills & competencies

senior regulatory affairs specialist

remote

somerville ma listing location

radnet

deephealth

medical devices

digital products

artificial intelligence

fda submissions

510(k)

regulatory compliance

travel approximately 10%

Work arrangement

• Weekend coverage required

Why this role

Remote work; role supports digital products, including AI technologies; travel is approximately 10% of the time.

About the employer

RadNet is hiring for this role. Industry: Offices of Physicians (except Mental Health Specialists). Sector: 62.