Senior Manager, International Regulatory Affairs

Valencia, CA – Hybrid

 

 

Senior Manager, International Regulatory Affairs

 

 

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

 

 

Responsibilities: 

• Develops and executes global regulatory strategies for medical devices, telecom, and battery products across LATAM, MENA, and APAC, ensuring compliance with international standards.
• Manages 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.
• Leads and coaches teams, driving performance management, employee engagement, goal setting, and adherence to company policies while fostering a dynamic, improvement-focused work environment.
• Provides regulatory intelligence and guidance to cross-functional teams, aligning strategies with commercial objectives and ensuring compliance in labeling, technical requirements, and external standards.
• Builds and maintains strong relationships with regulatory authorities, local stakeholders, and internal departments, serving as the primary contact for regulatory projects.
• Oversees complex regulatory documentation and processes, ensuring timely submissions, effective communication with leadership, and readiness for regulatory audits.
• Supports organizational strategy and operations by contributing to budget planning, leading cross-divisional projects, and implementing processes that align regulatory activities with global business priorities.

 

 

More about you: 

• 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 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*