Senior Regulatory Affairs Lead – Medical Devices

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

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.