Senior Specialist, International Regulatory Affairs

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At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

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Senior Specialist, International (China) Regulatory Affairs

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.

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 200

Mb/sec download and 10

Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Don't meet all the criteria? If you’re willing to go allin and learn we'd love to hear from you!

What we offer :

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent…