Senior Regulatory Affairs Specialist

Job Title Senior Regulatory Affairs Specialist Location Austin, TX Summary We are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory strategies and manage product submissions for enabling technologies in the orthopedic industry. This role will involve hardware and software medical devices (SaMD) and will champion regulatory strategies, liaise with authorities, and facilitate the use of machine learning and AI in our portfolio. Key Responsibilities Develop and champion regulatory strategies and work with cross‑functional teams. Coordinate with FDA, Notified Body, and TGA for pre‑submission meetings. Partner with clinical affairs to develop clinical strategy and evaluations. Act as regulatory representative on product development teams, providing input on predicate identification, verification and validation testing, risk management, and standard conformance. Prepare submissions and technical documentation for product approvals in the US, EU, and Australia, respond to reviewers and resolve deficiencies. Coordinate with Corporate Market Access team to support international registrations and maintain licenses and certifications through renewals. Conduct regulatory assessments on product or process changes and execute notifications, new 510(k)s, letters to file, technical file updates, license amendments. Review and approve QMS change orders, design change orders, and NCRs. Review labeling and marketing collateral for regulatory compliance. Own and manage specific regulatory CAPAs and drive root‑cause investigations. Support HHEs, field actions, and recalls. Monitor industry‑applicable regulations, guidance, and standards; support compliance initiatives. Maintain regulatory metrics and report on processes. Participate in review of engineering specifications and quality programs. Collaborate with Sales, Operations, and other functions to provide QA/RA guidance. Align local RA activities with global policies and standards. Qualifications & Experience Bachelor’s degree in science, biomedical engineering, regulatory affairs, or related field. 7–8 years of experience in regulatory affairs in medical devices or related industry. Experience preparing regulatory submissions in the US, EU, and TGA (510(k), Technical Documentation, Conformity Assessments). International regulatory experience is a plus. Experience with products that use machine learning and/or AI is a plus. Expertise in US, EU, TGA regulations, ISO 13485, ISO 14971, MTAA Code of Practice. Ability to work independently while collaborating across organization. Strong analytical, problem‑solving, and communication skills. Knowledge of quality management and continuous improvement principles. Commitment to Enovis values, mission, and vision. Sponsorship Currently, Enovis does not provide visa sponsorship and will not offer such sponsorship in the future. Applicants must already have full‑time work authorization in the United States. Equal Employment Opportunity Enovis provides equal employment opportunities based on merit, experience, and other work‑related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis. Benefits Medical Insurance Dental Insurance Vision Insurance Spending and Savings Accounts 401(k) Plan Vacation, Sick Leave, and Holidays Income Protection Plans Discounted Insurance Rates Legal Services #J-18808-Ljbffr KICO Knee Innovation Company Pty Limited (inactive)