Hiring: Regulatory Affairs Specialist I - Spine Company: Arthrex Location: Naples, FL Job Posted Time: 2026-09-10 15:15:18 Employment Type: On-site Target Skills & Keywords : Clinical Documentation, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, SAP About the job Experience: •Orthopedic medical device experience preferred. Required Skills: •Provide project teams with on-going support to resolve any real or perceived regulatory issues. •Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance. •Coordinate, prepare, write, submit and/or review regulatory submissions for projects in accordance with established product launch or other applicable timelines. •Coordinate efforts with regional counterparts associated with the preparation of international regulatory documents or submissions. •Review regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures to ensure all data and information is truthful, accurate and verifiable against source documentation to confirm compliance and traceability. •Establish, develop and maintain positive relationships with regulatory agency personnel. •Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products. •Maintain current knowledge base of existing and emerging regulations, standards, and/or guidance documents. Qualifications: •Machine, Tools, And/or Equipment Skills •Proficiency in the use of personal computers and computer programs, particularly SAP, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company). •Bachelor’s degree required, engineering or science discipline preferred. •Advanced degree preferred. •Regulatory Affairs Certification (RAC) preferred. Compensation: •Medical, Dental and Vision Insurance 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!