Specialist, International (China) Regulatory Affairs
Sonova AG
Summary
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.
Job description
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
More about you
- 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; experience with Agile PLM, SAP, and Regulatory Information Management Systems preferred
- English required; Chinese highly preferred
Travel: Up to 10% travel may be required. A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.
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
- Experience with Agile PLM, SAP, and Regulatory Information Management Systems preferred
- English required
- Chinese highly preferred
Benefits
- Medical, Dental & Vision
- Health Savings Account
- Health Reimbursement Account
- Flexible Spending Account
- Dependent Care Account
- Telehealth Options
- 401(k) Matching
- Company Paid Life Insurance
- Company Paid AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Accident Insurance
- Hospital Indemnity
- Legal Assistance
- ID Theft Assistance
- Paid Time Off
- Paid Holidays
- Paid Parental Bonding Leave
- Employee Assistance Program
- Tuition Reimbursement
- Hearing Aid Discount
Company overview
Sonova Holding AG is a globally recognized Swiss medical device company specializing in innovative hearing care solutions. Founded in 1947 and headquartered in Stäfa, Switzerland, Sonova has established itself as one of the world's largest providers in the hearing care sector, holding approximately 24% of the global hearing aid market. The company operates through four core business divisions: Hearing Instruments, Audiological Care, Consumer Hearing, and Cochlear Implants. Sonova's diverse portfolio includes renowned brands such as Phonak, Unitron, Advanced Bionics, AudioNova, and licensed Sennheiser products. With over 17,990 employees worldwide, the company generates annual revenues exceeding CHF 3.6 billion and serves customers in more than 100 countries. Sonova's comprehensive offerings range from digital hearing aids and cochlear implants to wireless communication systems and professional audiological care services. As a component of the Swiss Market Index, Sonova maintains research facilities in Switzerland, Canada, and the United States, with manufacturing plants strategically located across Switzerland, China, and Vietnam. The company's mission centers on enabling people to experience the joy of hearing and live life without limitations through cutting-edge audio technology and comprehensive hearing care solutions.