Senior Manager, International Regulatory Affairs

Valencia, CA – Hybrid

The Senior Manager International Regulatory Affairs develops, implements regulatory programs and manages/leads International pre‑market and post‑market registrations for medical devices, telecommunications and other products as applicable.

• Develop and execute global regulatory strategies for medical devices, telecom, and battery products across LATAM, MENA, and APAC (excluding China), ensuring compliance with international standards.
• Manage pre‑ and post‑market registrations and submissions, including homologation for Class III medical devices, battery certification, and telecom approvals, delivered on time to support product launches.
• Lead and coach cross‑functional teams, driving performance management, employee engagement, goal setting, and adherence to company policies while fostering a dynamic, improvement‑focused work environment.
• Provide regulatory intelligence and guidance to cross‑functional teams, aligning strategies with commercial objectives and ensuring compliance in labeling, technical requirements, and external standards.
• Build and maintain strong relationships with regulatory authorities, local stakeholders, and internal departments, serving as the primary contact for regulatory projects.
• Oversee complex regulatory documentation and processes, ensuring timely submissions, effective communication with leadership, and readiness for regulatory audits.
• Support organizational strategy and operations by contributing to budget planning, leading cross‑divisional projects, and implementing processes that align regulatory activities with global business priorities.

• Education: Bachelor’s degree required; preferred in Engineering or Regulatory Affairs.
• Experience: Minimum 10 years in GMP, QSR, and ISO‑regulated medical device environments, with at least 5 years in regulatory affairs and medical devices.
• Leadership: At least 4 years of progressive management experience, including leading cross‑functional and geographically dispersed teams.
• Specialized Knowledge: Previous Class III medical device experience preferred; strong understanding of global telecom and battery regulations.
• Competencies: Highly collaborative, adaptable, self‑motivated, with strong interpersonal and communication skills to influence and drive change.
• Professional
  
  Skills:
  
  Strong analytical, decision‑making, organizational, and presentation abilities; proven capacity to manage shifting priorities and foster a quality‑focused culture.
• Technical & Language
  
  Skills:
  
  Proficiency in MS Office and database management for regulatory tracking; fluent in English, bilingual preferred.

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 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.

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• Tele Health options
• 401k plan with company match*
• Company paid life, disability insurance
• Additional supplemental life, disability coverage available
• Company paid Short/Long‑Term Disability coverage (STD/LTD)
• STD LTD buy‑ups available
• Accident/Hospital indemnity coverage
• Legal/ assistance
• PTO (or sick and vacation time), floating diversity day, and 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…