Sonova

3 weeks ago

Senior Specialist, International Regulatory Affairs (Valencia (CA), United States)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Senior regulatory specialist to drive global regulatory activities for Class III medical devices across LATAM/EMEA/APAC, coordinating with in-country teams, preparing submissions, and guiding regulatory strategies for international markets.

Location: United States

Workplace: Hybrid

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

•Plan and execute global regulatory activities to obtain and maintain approvals in international markets, including LATAM, EMEA, and APAC
•Prepare international submissions, registration documentation, renewals, annual reports, and responses to regulatory authority requests
•Support local in-country Regulatory Affairs affiliates to help ensure timely approvals and continued product access
•Review product changes and assess regulatory impact on international regulatory strategies and submissions
•Provide regulatory input for sustaining and new product development projects, including country-specific requirements

Travel: Low travel

Pay and Benefits

Salary: 125,400

Perks:Health Insurance401kPaid Leave

Key Requirements

•Bachelor’s degree required, or equivalent work experience
•5–8 years of experience in pre-market and/or post-market medical device Regulatory Affairs
•Experience with global regulations and maintaining certifications throughout the life of a medical device
•Experience providing regulatory strategy and guidance for Outside U.S. and EU markets, including MENA, APAC, and LATAM
•Travel up to 10% may be required

Experience:5-8 yearsMedical devicesRegulatory affairs

Education:Bachelor's

Skills:WritingTime managementProblem-solvingIndependenceCommunication

Languages:English

Tech Stack:Microsoft OfficeAgile PLMSAPRegulatory Information Management Systems

Company Brief

Sonova

Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Stäfa, Switzerland

Founded: 1947

Website

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Sonova

3 weeks ago

Senior Specialist, International Regulatory Affairs (Valencia (CA), United States)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Hybrid

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

•Plan and execute global regulatory activities to obtain and maintain approvals in international markets, including LATAM, EMEA, and APAC
•Prepare international submissions, registration documentation, renewals, annual reports, and responses to regulatory authority requests
•Support local in-country Regulatory Affairs affiliates to help ensure timely approvals and continued product access
•Review product changes and assess regulatory impact on international regulatory strategies and submissions
•Provide regulatory input for sustaining and new product development projects, including country-specific requirements

Travel: Low travel

Pay and Benefits

Salary: 125,400

Perks:Health Insurance401kPaid Leave

Key Requirements

•Bachelor’s degree required, or equivalent work experience
•5–8 years of experience in pre-market and/or post-market medical device Regulatory Affairs
•Experience with global regulations and maintaining certifications throughout the life of a medical device
•Experience providing regulatory strategy and guidance for Outside U.S. and EU markets, including MENA, APAC, and LATAM
•Travel up to 10% may be required

Experience:5-8 yearsMedical devicesRegulatory affairs

Education:Bachelor's

Skills:WritingTime managementProblem-solvingIndependenceCommunication

Languages:English

Tech Stack:Microsoft OfficeAgile PLMSAPRegulatory Information Management Systems

Company Brief

Sonova

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Stäfa, Switzerland

Founded: 1947

Website