Principal Regulatory Affairs Specialist - Software Devices
About the job
- A bachelor's degree in Engineering, Science, or a relevant technical discipline is required.
- At least nine years of Regulatory Affairs-related experience in a medically regulated environment is required, including at least seven years in a US FDA Class II medical device company and two years of software medical device (SaMD, SiMD) experience.
- Provide regulatory guidance to product development and sustaining project teams as the Regulatory representative.
- Author US FDA premarket submissions, including 510(k) and Q-submissions, and international submissions for medical devices, including software devices (SaMD, SiMD), collaborating with key staff in Product Development, Operations, Marketing, and Quality to support timely submissions.
- Serve as the primary contact for regulatory agencies on assigned submissions and negotiate submission data requirements and deliverables with regulatory authorities and product development teams to support timely clearance.
- Author regulatory assessments for proposed product or process changes.
- Collaborate with Marketing, Sales, Legal, and Regulatory partners to review advertising and promotional materials and product labeling in a timely manner.
- Monitor regulatory landscape changes and author impact assessments for proposed or issued regulatory guidance, directives, and legislation; interpret changes for implementation into company processes.
- Maintain US FDA and international registrations and device listings.
- Support the Unique Device Identifier (UDI) program and US FDA Global Unique Device Identification Database (GUDID) submissions.
- Maintain regulatory data, files, and daily regulatory operations.
- Participate in audits by regulatory authorities, certification bodies, or internal auditors.
- Mentor junior Regulatory staff and guide cross-functional understanding of applicable regulatory requirements and processes.
- Develop regulatory training for departmental and cross-functional understanding of regulatory requirements and procedures.
- Develop regulatory processes and procedures to improve departmental efficiency.
- Regulatory Affairs Certification US (RAC) through the Regulatory Affairs Professional Society (RAPS) is preferred.
About the company
Treace Medical Concepts designs, manufactures, and markets orthopedic surgical systems for foot and ankle care, focusing on bunion correction and midfoot deformities. Its flagship Lapiplasty 3D Bunion Correction System uses patented instruments, implants, and a multi-plane approach with Biplanar plating to correct bunions at the root and enable faster weight-bearing. The company also offers Adductoplasty for coexisting midfoot deformities, Hammertoe PEEK Fixation, and SpeedPlate bone-fusion systems, selling kits through a direct sales force and distributors to physicians, ambulatory surgery centers, and hospitals. Treace aims to grow its portfolio and market leadership in foot-and-ankle devices by expanding adoption and improving surgical outcomes.
Company Size
201-500
Company Stage
IPO
Headquarters
Ponte Vedra Beach, Florida
Founded
2014
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Simplify's Take
What believers are saying
- Q2 2026 case volumes grew high single digits, and 40% of surgeons adopted new systems.
- Management raised 2026 revenue guidance to $204 million-$212 million on August 7, 2026.
- SuperBite and HyperPlate XM reached first cases in 2026, broadening addressable market $300 million.
What critics are saying
- Q2 2026 revenue fell 4%, and lower-priced products still pressure margins.
- Treace finished June 2026 with $45.6 million cash, while growth depends on Q3 launches.
- If Lapiplasty share erodes, Treace becomes a commoditized foot-and-ankle kit vendor.
What makes Treace unique
- Treace’s Lapiplasty owns a patented 3D bunion workflow surgeons already know.
- September 2026 AOFAS launches extend one salesforce across bunions, midfoot, hindfoot, and fusions.
- Cloud X-ray, SuperBite, and HyperPlate create a stickier, procedure-spanning surgeon platform.
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Benefits
- Parental Leave
- 401(k) Company Match
- Company Equity
- Unlimited Paid Time Off