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Sonova Group · 9 hours ago

Senior Specialist, International Regulatory Affairs

Santa Clarita, CA

Full-time

Hybrid

Senior Level

$82K/yr - $124K/yr

5+ years exp

Sonova Group is focused on regulatory compliance in the medical devices sector, and they are seeking a Senior Specialist in International Regulatory Affairs. This role involves planning and executing global regulatory activities to obtain and maintain approvals in international markets, primarily supporting regulatory efforts in China.

Medical Device

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

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

Qualification

Regulatory AffairsChina Regulatory SubmissionsProject ManagementMedical Devices ExperienceGlobal Regulatory FrameworksCross-Functional Team LeadershipStakeholder CoordinationMicrosoft OfficeAgile PLMSAPRegulatory SystemsEnglish ProficiencyChinese Language ProficiencyCommunication Skills

Required

Bachelor's degree in a technical/scientific field or equivalent experience

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)

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Proficient in Microsoft Office, Agile PLM, SAP, and regulatory systems