Senior Regulatory Affairs Specialist

Senior Specialist, International Regulatory Affairs Job ID: 164201 Advanced Bionics is seeking a Senior Specialist, International Regulatory Affairs to support global regulatory activities for Class III medical devices. This role is responsible for helping obtain and maintain regulatory approvals in international markets, supporting local in‑country Regulatory Affairs teams, preparing submissions, assessing regulatory impact of product changes, and ensuring ongoing compliance with applicable global regulations and standards. Responsibilities Plan and execute global regulatory activities to obtain and maintain approvals in international markets, including LATAM, EMEA, and APAC. Prepare international submissions, registration documentation, renewals, annual reports, and responses to regulatory authority requests. Support local in‑country Regulatory Affairs affiliates to help ensure timely approvals and continued product access. Review product changes and assess regulatory impact on international regulatory strategies and submissions. Provide regulatory input for sustaining and new product development projects, including country‑specific requirements. Support pre‑market and post‑market regulatory compliance activities for international product approvals. Develop and maintain Regulatory Affairs procedures and support process improvement initiatives. Qualifications Bachelor’s degree required, or equivalent work experience. 5–8 years of experience in pre‑market and/or post‑market medical device Regulatory Affairs. Experience with global regulations and maintaining certifications throughout the life of a medical device. Experience providing regulatory strategy and guidance for outside U.S. and EU markets, including MENA, APAC, and LATAM. Strong writing, proofreading, data management, time management, and problem‑solving skills. Ability to work independently, manage multiple priorities, and adapt when priorities change. Proficiency in Microsoft Office; experience with Agile PLM, SAP, and Regulatory Information Management Systems preferred. Travel Up to 10% travel may be required. Benefits Medical, dental and vision coverage* Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts TeleHealth options 401k plan with company match* Company paid life/ad&d insurance Additional supplemental life/ad&d coverage available Company paid Short/Long‑Term Disability coverage (STD/LTD) STD LTD Buy‑ups available Accident/Hospital Indemnity coverage Legal/ID Theft Assistance PTO (or sick and vacation time), floating Diversity Day, & paid holidays* Paid parental bonding leave Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more) Robust Internal Career Growth opportunities Hearing aid discount for employees and family Internal social recognition platform This role’s pay range is between $100,320 – $125,400. This role is also commission eligible/bonus eligible. How we work At Sonova, we prioritize the well‑being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team‑customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives. Equal Opportunity Employer We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status. #J-18808-Ljbffr