Senior Specialist, International (China) 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 regulatory activities for Class III medical devices, with a primary focus on China and Taiwan market registrations. This Valencia, CA-based role is responsible for helping obtain and maintain regulatory approvals, preparing local submissions, supporting in-country Regulatory Affairs representatives, assessing regulatory impact for product and process changes, and ensuring compliance with applicable pre-market and post-market requirements.
Requirements
- Bachelor’s degree required, or equivalent work experience
- Minimum 5 years of experience in pre-market and/or post-market medical device Regulatory Affairs
- Experience working on submissions and local testing for China and Taiwan preferred
- Knowledge of registration and standard requirements for China and Taiwan preferred
- Experience assessing product and process changes for international registrations
- Strong writing, proofreading, documentation organization, data management, time management, and problem-solving skills
- Proficiency in Microsoft Office
- English required
Nice To Haves
- Experience with Agile PLM, SAP, and Regulatory Information Management Systems preferred
- Chinese highly preferred
Responsibilities
- Develop and execute regulatory activities necessary to obtain and maintain approvals in China and Taiwan
- Prepare regulatory submissions, including Product Technical Requirement documents, registration documentation, renewals, annual reports, and responses to regulatory authority requests
- Partner with local in-country Regulatory Affairs representatives to support timely approvals and continued product access
- Participate in sustaining and new product development projects to provide local regulatory requirements
- Review new or amended regulations and standards, and help keep the company informed of local regulatory requirements
- Review product and process changes and assess regulatory impact on international registration strategy and submissions
- Create and update local SOPs and support Regulatory Affairs procedures and 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
