Principal Regulatory Lead - Medical Devices & SaMD

Treace Medical Concepts, Inc.; Ponte Vedra Beach (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Treace is seeking a Principal Regulatory Affairs Specialist to lead regulatory activities for software devices (SaMD/SiMD) in a fast-growing medical device environment. You will collaborate with Product Development, Quality, Operations, Marketing, and Legal to ensure timely submissions and compliant labeling.

The role emphasizes mentorship, process improvement, and staying ahead of regulatory changes. A strong track record in US FDA submissions and international registrations is essential.

Qualifications

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

Responsibilities

• Serves as the Regulatory representative guiding product development and sustaining project teams.
• Authors US FDA premarket submissions (e.g., 510(k)) and international submissions for medical devices, including SaMD/SiMD, with collaboration from key staff for timely submissions.
• Primary contact for regulatory agencies on assigned submissions and negotiates data requirements with authorities and product development teams for timely clearance.
• Authors regulatory assessments for proposed changes to products or processes.
• Collaborates with Marketing, Sales, Legal and Regulatory partners for timely review of advertising materials and product labeling.
• Monitors regulatory landscape changes and writes impact assessments for implementation into processes.
• Maintains US FDA and international registrations and device listings; supports GUDID submissions.
• Participates in audits by regulatory authorities, certification bodies, or internal auditors.
• Mentors junior Regulatory staff and develops regulatory trainings for cross-functional understanding.
• Develops regulatory processes and procedures for departmental efficiencies.

Skills

Regulatory strategy

FDA submissions

SaMD/SiMD

Cross-functional leadership

Technical writing

Education

Bachelor’s degree in Engineering/Science

Job description

Treace is seeking a Principal Regulatory Affairs Specialist to lead regulatory activities for software devices (SaMD/SiMD) in a fast-growing medical device environment. You will collaborate with Product Development, Quality, Operations, Marketing, and Legal to ensure timely submissions and compliant labeling.

The role emphasizes mentorship, process improvement, and staying ahead of regulatory changes. A strong track record in US FDA submissions and international registrations is essential.