Senior Specialist, International (China) Regulatory Affairs

Sonova
United States
Workplace: HybridFull timeUSD 100,320 - 125,400 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 5+ yearsEducation: bachelorsSkills: ["Writing","Proofreading","Documentation organization","Data management","Problem-solving"]

Support China and Taiwan regulatory activities for Class III medical devices, focusing on obtaining and maintaining registrations. Prepare product technical requirement documentation, renewals, annual reports, and responses to authorities. Partner with in-country Regulatory Affairs representatives, assess regulatory impact of product and process changes, review evolving regulations and standards, and create/update local SOPs and support process improvements.

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FursaFursa
Sonova
Sonova
1 day ago

Senior Specialist, International (China) Regulatory Affairs

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

Source: Company careers pageValidated by: Fursa AI
Last checked: 12 hours agoStatus: Live

Job Summary

Support China and Taiwan regulatory activities for Class III medical devices, focusing on obtaining and maintaining registrations. Prepare product technical requirement documentation, renewals, annual reports, and responses to authorities. Partner with in-country Regulatory Affairs representatives, assess regulatory impact of product and process changes, review evolving regulations and standards, and create/update local SOPs and support process improvements.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Develop and execute regulatory activities to obtain and maintain approvals in China and Taiwan.
  • •Prepare regulatory submissions, renewals, annual reports, and responses to regulatory authority requests.
  • •Partner with local in-country Regulatory Affairs representatives to support timely approvals and continued access.
  • •Support sustaining and new product development projects by providing local regulatory requirements.
  • •Review regulations/standards and assess regulatory impact of product and process changes; create/update local SOPs.
Travel: Low travel

Pay and Benefits

Salary: USD 100,320 - 125,400 annually
Perks:Health InsuranceDentalVision401kLife InsurancePaid HolidaysParental LeavePaid Leave

Key Requirements

  • •Bachelor’s degree required or equivalent work experience.
  • •5+ years of experience in pre-market and/or post-market medical device Regulatory Affairs.
  • •Experience preparing and supporting submissions and local testing for China and Taiwan preferred.
  • •Knowledge of registration and standard requirements for China and Taiwan preferred.
  • •Strong documentation, writing/proofreading, data management, and problem-solving skills.
Experience:5+ yearsMedical devicesRegulatory affairsInternational regulatory submissions
Education:Bachelor's
Skills:WritingProofreadingDocumentation organizationData managementProblem-solving
Languages:EnglishChinese
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