Sr. Regulatory Affairs Specialist II

Treace Medical Concepts, Inc.; Ponte Vedra Beach (FL); On-site; USD 110,000 - 140,000; Full time

Job summary

Treace Medical Concepts, Inc. seeks a Senior Regulatory Affairs Specialist II to lead regulatory support for product development and lifecycle management.

You will author FDA 510(k) and international submissions with input from Product Development, Operations, Marketing, and Quality, and coordinate with Regulatory authorities for timely clearance. Role requires a strong background in medical devices (US FDA Class II), and the ability to mentor junior staff while maintaining registrations,

Qualifications

• Bachelor's degree in engineering, science, or relevant technical discipline.
• Minimum 7 years of Regulatory Affairs experience in a medically regulated environment; at least 5 years in medical devices (US FDA Class II).
• RAC certification through RAPS preferred.

Responsibilities

• Serve as regulatory representative guiding product development and sustaining projects.
• Author US FDA submissions (510(k), Q-submissions) and international submissions with cross-functional input.
• Primary contact for regulatory agencies on submissions; negotiate data requirements with teams for timely clearance.
• Draft regulatory assessments for proposed product or process changes.
• Collaborate with Marketing, Sales, Legal and Regulatory on advertising, promotions, and labeling reviews.
• Monitor regulatory landscape changes and interpret implications for Treace processes.
• Maintain US FDA and international registrations and device listings.
• Support UDI requirements including GUDID and international submissions.
• Maintain regulatory data, files, and daily operations; participate in audits.
• Mentor junior staff and train cross-functional teams on regulatory requirements.
• Develop and implement new regulatory processes and conduct training.

Skills

Regulatory guidance

Cross-functional collaboration

Regulatory submissions

Mentoring

Education

Bachelor's degree in Engineering, Science, or relevant technical discipline

RAC certification preferred

Tools

GUDID database

Regulatory databases

Job description

Job Description

The Senior Regulatory Affairs Specialist II 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 meet all applicable regulatory requirements. The Senior Regulatory Affairs Specialist II will work with Marketing, Sales, Legal, and Regulatory partners on advertising and promotional materials as well as product labelling while meeting all applicable regulatory requirements. The Senior Regulatory Affairs Specialist II 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 submissions (e.g., 510(k), Q-submissions) and international submissions 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) requirements including US FDA Global Unique Device Identification Database (GUDID) and international UDI 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 and implements new Regulatory processes and procedures and conducts Regulatory trainings for departmental and cross-functional understanding of regulatory requirements and procedures.

Minimum Requirements

• Bachelor’s degree in Engineering, Science, or relevant technical discipline is required.
• Minimum of 7 years of Regulatory Affairs related experience in a medically regulated environment with at least 5 years in a medical device company (US FDA Class II) is required.
• Regulatory Affairs Certification US (RAC) through Regulatory Affairs Professional Society (RAPS) is preferred.

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

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.