Regulatory Affairs Specialist

Regulatory Affairs Specialist The Regulatory Affairs Specialist is responsible for supporting the development, execution, and maintenance of regulatory strategies to ensure compliance with applicable global regulations for medical devices. This role will play a critical part in supporting product registrations, regulatory submissions, labeling and promotional review, and ongoing regulatory compliance activities. The role will also support the company’s expanding presence in promotional activities, conferences, symposiums, and market expansion initiatives by ensuring all materials and activities meet regulatory standards. This position is onsite in Fort Worth, Texas. Duties and Responsibilities Regulatory Strategy & Submission Suppor t Support the execution of regulatory strategies for new and existing products. Prepare, compile, and maintain regulatory submissions (e.g., 510(k), technical documentation, license renewals, and international registrations). Coordinate submission activities and timelines to ensure timely regulatory approvals. Maintain regulatory files including Technical Files, Design Dossiers, and submission archives. Regulatory Compliance & QMS Integration Ensure compliance with applicable regulatory requirements including FDA 21 CFR Part 820, ISO 13485, MDSAP, and international regulations. Support integration of regulatory requirements into the Quality Management System (QMS). Participate in internal and external audits and inspections; support responses to regulatory agencies. Monitor regulatory changes and assess impact on company products and processes. Labeling, Promotion & Commercial Support Review and approve product labeling, IFUs, and packaging to ensure regulatory compliance. Review promotional materials, marketing campaigns, conference materials, and symposium content for regulatory compliance. Support increased commercial activities including HCP engagement programs, dinner programs, and conference participation. Ensure claims are accurate, substantiated, and compliant with applicable regulations. Global Regulatory Support Support regulatory activities for international markets including Canada, LATAM, and Asia. Assist with product registrations, renewals, and regulatory notifications for global markets. Coordinate with international regulatory partners, distributors, and notified bodies as needed. Risk Management & Compliance Support Support risk management activities in accordance with ISO 14971. Assist in evaluating regulatory impact of deviations, CAPAs, and change controls. Ensure regulatory considerations are incorporated into product lifecycle decisions. Competencies Strong organizational and project management skills. Ability to interpret and apply complex regulatory requirements. Ability to work cross-functionally in a fast‑paced environment. Analytical thinking and problem‑solving capability. Key Behavior Skills Strong attention to details Strong interpersonal and communication skills Proactive and self‑driven Collaborative mindset Requirements Bachelor’s Degree required, preferably in Life Sciences, Regulatory Affairs, or related field. 3–6 years of experience in Regulatory Affairs within the medical device industry. Experience with regulatory submissions (e.g., 510(k), device technical files). Working knowledge of FDA regulations (21 CFR Part 820) and ISO 13485. Familiarity with global regulatory requirements (e.g., MDR, Health Canada, LATAM regulations). Preferred Qualifications RAC (Regulatory Affairs Certification) preferred. Experience supporting promotional material review and advertising compliance. Experience with combination products or antimicrobial/wound care devices. Knowledge of MDSAP and international regulatory frameworks. Work Environment Indoors, no adverse environmental conditions expected. 0‑5% Travel Physical Demands Ability to sit, stand, and work at a computer for extended periods. Ability to occasionally lift up to ten (10) pounds. Must be able to perform essential functions for an 8‑hour workday. Benefits Health Insurance Dental Insurance Vision Insurance Company‑paid and voluntary life Insurance Company‑paid disability insurance and benefits EAP 401(k) with company match Paid time off Paid family leave Salary Description $75,000 - $90,000, bonus eligible Equal Opportunity Employer EQUAL OPPORTUNITY EMPLOYER. It is our policy to abide by all federal, state and local laws prohibiting employment discrimination based solely on a person’s race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, or any other protected status except where reasonable, bona fide occupational qualification exists. Urgo Medical North America participates in EVerify for all employees. #J-18808-Ljbffr Urgo Medical North America LLC