Senior Manager, International Regulatory Affairs
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Job Location:
Valencia, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
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: Bachelors 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
Dont meet all the criteria If youre willing to go allin and learn wed 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 roles pay range is between:$126400/yr - $189600/yr. This role is also 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.
Required Experience:
Senior Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Around 25% of the world’s population is living with hearing loss. At Sonova, we envision a world where everyone enjoys the delight of hearing and lives a life without limitations. From hearing aids to cochlear implants to wireless communication, we are committed to offering the most c ... View more
