Senior Specialist, International Regulatory Affairs
Sonova AG•Santa Clarita, CA
•$100,320 - $125,400•Hybrid
About The Position
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.
Requirements
- 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
Nice To Haves
- experience with Agile PLM, SAP, and Regulatory Information Management Systems preferred
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
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
- Tuition reimbursement
- Hearing aid discount for employees and family
- Internal social recognition platform
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What This Job Offers
Job Type
Full-time
Career Level
Senior
