Senior Specialist, International Regulatory Affair (Valencia (CA), United States) en Sonova

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:

• This position ensures compliance with required global regulations and serves as a key team member and/or in a lead role on extended team(s)
• Execute regulatory activities necessary to obtain and maintain regulatory approvals in China
• Develop and execute global regulatory activities necessary to obtain and maintain regulatory approvals in international markets (such as, LATAM, MENA, APAC).
• Provide support to local In-country RA affiliates who interact with regulatory authorities to assure timely approvals and continued product access
• Prepare submissions, interact effectively with regulatory agencies and negotiate submission issues as needed
• Participate and represent OUS regulatory function in sustaining and new product development projects to provide OUS regulatory requirements
• Assist in keeping company informed of regulatory requirements and external standards in international markets
• Prepares International submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements
• Supports International product demand planning and release activities
• Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures
• Supports post market regulatory compliance activities for international product approvals
• Develops and maintains regulatory affairs department procedures and process improvements
• Other duties as assigned or required

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:

• Bachelor’s Degree (and/or 8-10 years of equivalent work experience)
• Bachelor's degree in a technical or scientific field (e.g., Biochemistry, Biomedical, Electrical, or Chemical Engineering), or equivalent practical experience
• M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• 5-8 years of experience in pre/post market medical device regulatory affairs
• Proven ability to manage end-to-end project timelines and deliverables for China-specific testing and regulatory submissions, ensuring compliance with local standards and coordination across internal and external stakeholders.
• Experience in global regulations and maintaining certifications for the life of a medical device
• Experience leading cross-functional teams
• Experience providing regulatory strategy and guidance for Outside US and EU markets, (MENA, APAC, LATAM)
• Experience in Telecom and Battery registrations is strongly preferred
• In-depth knowledge in Chinese regulations and standards for class IIII, II, and I devices
• Good working knowledge of Global regulations and standards.
• English (Spoken, Written) required, Chinese capability strongly preferred.
• Proficiency in Microsoft Office suite.
• Experience with Agile PLM, SAP and Regulatory Information Management 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

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: $82,400/yr - $123,600/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.