Principal Regulatory Affairs Specialist - Software Devices

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

Principal Regulatory Affairs Specialist - Software Devices

• Full-time

At Treace, we are revolutionizing 3D solutions for the treatment of complex bunion deformities. Our innovative, high-velocity approach enables us to consistently exceed customer expectations, delivering minimally invasive solutions that improve patient outcomes and drive efficiency for healthcare providers. By advancing reproducibility and patient satisfaction, Treace empowers foot and ankle surgeons to achieve better surgical results, reduce healthcare costs, and enhance overall care quality.

If you're seeking an opportunity to grow in your career while working with a dynamic and diverse team dedicated to meaningful innovation, Treace could be your next great career destination. Together, let's create something greater than ourselves.

POSITION SUMMARY

The Principal Regulatory Affairs Specialist will report to the Director of Regulatory Affairs and will work with Product Development, Quality, Operations, and Marketing to support the product development process and meeting all applicable regulatory requirements. The Principal Regulatory Affairs Specialist will work with Marketing, Sales, Legal and Regulatory partners on advertising and promotional materials as well as product labeling while meeting all applicable regulatory requirements. The Principal Regulatory Affairs Specialist will support daily regulatory operations and regulatory data management as well as monitor and assess applicable regulatory landscape changes.

PRIMARY DUTIES AND RESPONSIBILITIES

• Serves as the Regulatory representative providing regulatory guidance to product development and sustaining project teams.
• Authors US FDA premarket submission (e.g., 510(k), Q-submissions) and international submissions for medical devices, including software devices (SaMD, SiMD), with collaboration from key staff in Product Development, Operations, Marketing, and Quality for timely submissions.
• Serves as primary contact for regulatory agencies on assigned submissions and negotiates submission data requirements and deliverables with regulatory 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 and promotional materials as well as product labeling.
• Monitors regulatory landscape changes and authors impact assessments to key proposed or issued regulatory guidance, directives, and legislation. Interprets changes for implementation into TMC processes.
• Maintains US FDA and international registrations and device listings.
• Supports the Unique Device Identifier (UDI) program and US FDA Global Unique Device Identification Database (GUDID) submissions.
• Maintains regulatory data, files, and daily regulatory operations.
• Participates in audits by regulatory authorities, certification bodies, or internal auditors.
• Mentors junior Regulatory staff and guides for cross-functional understanding of applicable regulatory requirements and processes.
• Develops Regulatory trainings for departmental and cross-functional understanding of regulatory requirements and procedures.
• Develops Regulatory processes and procedures for departmental efficiencies.

MINIMUM REQUIREMENTS

All your information will be kept confidential according to EEO guidelines.

Education and Experience

• Bachelor’s degree in Engineering, Science, or relevant technical discipline is required.
• Minimum of nine (9) years of Regulatory Affairs related experience in a medically regulated environment with at least seven (7) years in a medical device company (US FDA Class II) and two (2) years software medical device (SaMD, SiMD) experience is required.
• Regulatory Affairs Certification US (RAC) through Regulatory Affairs Professional Society (RAPS) is preferred.

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer

Treace is a drug free employer.