Principal Regulatory Affairs Specialist – Software Devices

🔥 34 minutes ago

🐊 Florida – Remote

🐊 Florida – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 15%

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Treace Medical Concepts, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

Treace Medical Concepts, Inc. is a commercial-stage orthopaedic medical device company dedicated to improving the surgical management of bunion deformities and related midfoot correction. They have developed and patented the Lapiplasty® 3D Bunion Correction™ system, which uses specialized instruments and implants for comprehensive correction of bunions, addressing all three planes of the deformity. This innovative solution targets the root cause of bunions and assists patients in returning to active lifestyles. Treace has also introduced the Adductoplasty™ Midfoot Correction System, further enhancing their offerings for hallux valgus patients.

📋 Description

• Provide regulatory guidance to product development and sustaining project teams • Author US FDA premarket submissions, including 510(k) and Q-submissions, and international submissions for medical devices and software devices • Collaborate with Product Development, Operations, Marketing, and Quality for timely submissions • Serve as primary contact for regulatory agencies on assigned submissions • Negotiate submission data requirements and deliverables with regulatory authorities and product development teams • Author regulatory assessments for proposed product or process changes • Review advertising, promotional materials, and product labeling with Marketing, Sales, Legal, and Regulatory partners • Monitor regulatory landscape changes and author impact assessments • Interpret regulatory 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 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 regulatory requirements and processes • Develop Regulatory trainings • Develop Regulatory processes and procedures for departmental efficiencies

🎯 Requirements

• 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 • At least seven (7) years in a medical device company (US FDA Class II) • Two (2) years of software medical device (SaMD, SiMD) experience • Regulatory Affairs Certification US (RAC) through Regulatory Affairs Professional Society (RAPS) is preferred

🏖️ Benefits

• Full-time employment • Confidentiality of applicant information according to EEO guidelines • Equal employment opportunity protections • Drug-free workplace

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