Senior Specialist, International Regulatory Affair

Valencia CA Remote

Senior Specialist International Regulatory Affairs

The Senior Professional Regulatory Affairs implements and monitors regulatory programs and assists in the homologation of the product range.

The Senior Regulatory Affairs (RA) Specialist - International will plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals within international markets. Although this position may need to support any of the countries in APAC LATAM and MENA the main responsibility will be supporting China activities.

Responsibilities:

Ensure global regulatory compliance and lead or contribute to cross-functional teams.
Manage regulatory submissions and approvals for China and international markets (LATAM MENA APAC).
Collaborate with in-country regulatory affiliates to support timely product approvals and access.
Prepare and negotiate regulatory submissions addressing agency queries and documentation requirements.
Represent international regulatory interests in product development and lifecycle management projects.
Monitor and communicate evolving international regulatory requirements and standards.
Support post-market compliance product release planning and continuous improvement of regulatory processes.

Additional Key Responsibilities:

• Provides input to assure that applicable country regulatory requirements including EU MDR regulations and standards are incorporated in the product development process and design/ manufacture of the products.
• Review and assess the RA inputs document in order to discuss the project and its scope and determine country-specific requirements such as testing requirements labeling requirements as part of the Regulatory Inputs Documents.
• Produce subsequent submissions (License Renewals Annual Reports Additional Information Requests etc.) to facilitate the maintenance of these approvals.
• Ensure compliance with pre-market and post-market approval requirements.

Travelling Requirement: up to 10%

More about you:

Bachelors degree in a technical/scientific field or equivalent experience; advanced degrees (M.S. M.B.A. Ph.D.) and certifications (e.g. RAC) are preferred.
58 years of regulatory affairs experience in medical devices covering both pre- and post-market activities.
Proven expertise in China-specific regulatory submissions and testing with strong project management and stakeholder coordination.
Solid understanding of global regulatory frameworks and lifecycle certification maintenance including OUS markets (MENA APAC LATAM).
Experience leading cross-functional teams and handling Telecom and Battery registrations; deep knowledge of Chinese device classifications (Class IIII).
Strong communication skills in English (spoken/written); Chinese language proficiency preferred; proficient in Microsoft Office Agile PLM SAP and regulatory systems.

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: $82400/yr - $123600/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.