Sr. Regulatory Affairs Specialist II

Treace Medical Concepts, Inc.; Ponte Vedra Beach (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Treace Medical Concepts, Inc. seeks a Senior Regulatory Affairs Specialist II in Ponte Vedra Beach, Florida. This role involves providing regulatory guidance for product development, authoring US FDA submissions, and ensuring compliance with applicable regulations. Required qualifications include a Bachelor's degree in Engineering or Science and at least 7 years of Regulatory Affairs experience in a medical device setting. The position emphasizes teamwork and mentorship and offers an opportunity to influence regulatory processes directly.

Qualifications

• 7+ years of Regulatory Affairs experience in a medically regulated environment.
• 5+ years in a medical device company (US FDA Class II).
• Ability to mentor junior Regulatory staff.

Responsibilities

• Provide regulatory guidance to product development teams.
• Author US FDA premarket and international submissions.
• Negotiate submission data requirements with regulatory authorities.
• Monitor regulatory landscape changes.
• Maintain regulatory data and operations.

Skills

Regulatory guidance

US FDA submissions

Regulatory compliance

Data management

Mentorship

Education

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

Regulatory Affairs Certification (RAC)

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.