Senior Specialist, International Regulatory Affairs

Valencia, CA

Senior Specialist, International 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 200Mb/sec download and 10Mb/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 all in and learn we'd love to hear from you! 

We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources

 What we offer:

• 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

*Plan rules/offerings dependent upon group Company/location.

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.