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Senior Specialist, International Regulatory Affairs (Valencia (CA), United States)

@ Sonova
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Valencia, California, United States
$100k-$125k/yrHybridFull Time
Responsibilities:preparing submissions, supporting affiliates, maintaining approvals
Requirements Summary:Bachelor's degree or equivalent; 5–8 years medical device regulatory affairs experience; experience with global regulations and outside-US markets; strong writing, data management, time management, and problem-solving; Microsoft Office; Agile PLM, SAP, Regulatory Information Management Systems preferred.
Technical Tools Mentioned:Microsoft Office, Agile PLM, SAP, Regulatory Information Management Systems
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Job Description

Valencia, CA


 


Senior Specialist, International Regulatory Affairs


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.


 


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


 


More about you:


• 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; experience with Agile PLM, SAP, and Regulatory Information Management Systems 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.