Role Overview: The Regulatory Affairs Specialist II is responsible for supporting the development and implementation of the overall objectives and regulatory strategies that impacts the introduction of new products and market status of existing products, assist Regulatory Affairs management by supporting activities and processes as required to assure that products manufactured and/or distributed by Smith & Nephew Inc. are in full compliance with U.S. and all applicable global regulatory requirements. Responsibilities: Prepares international dossiers for EMEA, LATAM, APAC, and other key market affiliates, to obtain and maintain global regulatory approvals of products. Generates regulatory strategies for new and modified products, product support on change notifications and quality plans. Interacts with global regulatory agencies to obtain CFG, LoA, etc. as required for product registration. Provides regulatory support for global regulatory teams on international regulatory requirements. Provide customer service necessary regulatory / registration information for compliance and customer requests. Support manufacturing changes for compliance with applicable regulations, including EU MDR and international. Update company databases with required information and statuses for licenses, registrations, renewals, products, and other required data, i.e. GUID, DI, EUDAMED, RIMSYS etc. Update and maintain knowledge of current developments and changes to applicable laws, regulations, and industry standards. Support development of company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements. Provide support for internal and Regulatory Agency audits Build Quality into all aspects of job performance by maintaining compliance to all quality requirements. Participates in training and development activities as required and other duties as assigned. Location: Austin, TX Dallas, TX FT Worth, TX Memphis, TN Andover, MA Hybrid (must be local to one of these sites) Education: Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline Experience: 2 years' experience in Regulatory Affairs (medical device industry preferred) Competencies: Read, Understand and apply global regulations Technical knowledge of medical products Understanding of relevant procedures, practices, and associated medical terminology Knowledge of product development process and design control Excellent research and analytical skills; detail oriented Ability to manage multiple projects Ability to work and problem solve both independently and within a team. Ability to work within deadlines as imposed by government regulations and internal guidelines. Excellent written and oral communication. Prior experience with Product Lifecycle Management Systems and large-scale document management systems a plus Proficiency with SAP, Microsoft Office, Adobe, internet, Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions Requires sitting, talking or listening, more than 2/3 of the time. Walking or standing less than 1/3 of the time. Use of Hands to use computer or write documents less than 2/3 of the time. Ability to travel by air or motor vehicle both domestically and internationally required. Some overnight travel required. Searching for, lifting and carrying records weighing up to 25 points less than 1/3 of the time. Close vision (clear at 20 inches or less) required to review documents and operate personal computers more than 2/3 of the time Travel: 5-15% (Domestic and/or International) #LI-LS1 Smith Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.