Hiring: Sr. Regulatory Affairs Specialist II Company: Treace Medical Concepts, Inc. Location: Ponte Vedra Beach, FL Job Posted Time: 2026-09-10 11:20:38 About the job Experience: •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. •At least 5 years in a medical device company (US FDA Class II) is required. Required Skills: •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. Qualifications: •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 •Treace is a drug free employer. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!