Senior Specialist, International Regulatory Affairs

November 21

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $82.4k - $123.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Sonova Group

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Healthcare • Biotechnology • Consumer Hearing

Sonova Group is a global leader in innovative hearing care solutions, providing a range of products including personal audio devices, hearing aids, cochlear implants, and audiological care services. Established in 1947 and headquartered in Stäfa, Switzerland, Sonova operates through multiple business units such as Hearing Instruments and Audiological Care, alongside well-known brands like Phonak and Unitron. With a presence in over 100 countries, Sonova is dedicated to improving the lives of those with hearing loss through advanced technology and comprehensive care.

10,000+ employees

Founded 1947

🧬 Biotechnology

📋 Description

• 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. • 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.

🎯 Requirements

• Bachelor’s 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. • 5–8 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 I–III). • 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

🏖️ Benefits

• 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