Senior Regulatory Affairs Lead for SaMD & Medical Devices

Treace Medical Concepts, Inc.; Ponte Vedra Beach (FL); On-site; USD 140,000 - 190,000; Full time

Job summary

Treace Medical Concepts, Inc. is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategy and ensure compliance across product development, quality, operations and marketing.

You will author 510(k) submissions, manage global registrations, and mentor junior staff in a fast-paced medical device environment. The role collaborates with cross-functional teams to ensure timely regulatory clearance and adherence to evolving regulations, supporting product labeling and advertising

Qualifications

• Bachelor’s degree in Engineering, Science, or relevant technical discipline.
• Minimum of nine (9) years of Regulatory Affairs experience in a medically regulated environment with at least seven (7) years in a medical device company and two (2) years software medical device experience.
• Regulatory Affairs Certification US (RAC) preferred.

Responsibilities

• Provide regulatory guidance to product development and sustaining teams.
• Author US FDA submissions (510(k), Q-submissions) and international submissions for medical devices including SaMD/SiMD.
• Serve as primary contact for regulatory agencies and negotiate data requirements for timely clearance.
• Prepare regulatory assessments for proposed product or process changes.
• Coordinate with Marketing, Sales, Legal on advertising, labeling, and promotional materials.
• Monitor regulatory landscape changes and assess impact for company processes.
• Maintain FDA and international registrations and device listings.

Skills

Regulatory guidance

FDA submissions

Cross-functional collaboration

Regulatory landscape monitoring

Mentoring

Education

Bachelor’s degree in Engineering/Science

RAC certification preferred

Job description

Treace Medical Concepts, Inc. is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategy and ensure compliance across product development, quality, operations and marketing.

You will author 510(k) submissions, manage global registrations, and mentor junior staff in a fast-paced medical device environment. The role collaborates with cross-functional teams to ensure timely regulatory clearance and adherence to evolving regulations, supporting product labeling and advertising