Principal Regulatory Affairs Specialist — Software Devices

Job overview

The Principal Regulatory Affairs Specialist — Software Devices role is onsite in Ponte Vedra, FL; compensation is not specified. The role supports Treace’s development of solutions for complex bunion deformities and works with Product Development, Quality, Operations, and Marketing. The specialist guides regulatory compliance across medical-device and software-device development, submissions, labeling, and promotional review. The role helps teams meet applicable requirements, secure timely clearances, and maintain regulatory operations and records.

What you'll do

• Provide regulatory guidance to product development and sustaining teams
• author US FDA premarket and international submissions for medical devices, including SaMD and SiMD
• serve as contact for regulatory agencies on assigned submissions
• author regulatory assessments for product or process changes
• review advertising, promotional materials, and labeling with partners
• monitor regulatory changes and assess impacts
• maintain registrations, device listings, UDI program support, GUDID submissions, regulatory files, and daily operations
• participate in audits
• mentor junior staff and develop training, processes, and procedures.

What we're looking for

Skills & competencies

principal regulatory affairs specialist

software devices

medical devices

samd

simd

fda submissions

regulatory compliance

udi

ponte vedra fl

treace

cross-functional collaboration

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in engineering, science, or a relevant technical discipline; nine years of regulatory affairs experience, including seven years in a medical-device company and two years with software medical devices. US RAC certification is preferred.

About the employer

Treace is hiring for this role. Industry: Offices of All Other Miscellaneous Health Practitioners. Sector: 62.