Regulatory Analyst (Sao Paulo  , Brazil)

Sonova
São Paulo
Workplace: HybridFull timeFunction: Quality & Regulatory (Non-Software)Education: high_schoolSkills: ["Regulatory compliance","Documentation management","Attention to detail","Stakeholder communication","Process follow-up"]

Execute and support regulatory affairs activities to ensure timely preparation, organization, and tracking of documentation and processes for product registration, approval, certification, and maintenance. Support submissions and maintenance with Brazilian regulators (INMETRO, ANATEL, ANVISA), prepare ANVISA product dossiers (classes II and IV), perform regulatory compliance monitoring, manage regulatory documentation integrity, and support regulatory audits and inspections.

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FursaFursa
Sonova
Sonova
1 day ago

Regulatory Analyst (Sao Paulo  , Brazil)

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

Source: Company careers pageValidated by: Fursa AI
Last checked: 11 hours agoStatus: Live

Job Summary

Execute and support regulatory affairs activities to ensure timely preparation, organization, and tracking of documentation and processes for product registration, approval, certification, and maintenance. Support submissions and maintenance with Brazilian regulators (INMETRO, ANATEL, ANVISA), prepare ANVISA product dossiers (classes II and IV), perform regulatory compliance monitoring, manage regulatory documentation integrity, and support regulatory audits and inspections.
Location: São Paulo
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Ensure preparation, organization, and tracking of regulatory documentation and processes for product registration, approval, certification, and maintenance.
  • •Support preparation and follow-up of registration, renewal, change, homologation, and certification processes with INMETRO, ANATEL, and ANVISA.
  • •Create ANVISA product dossiers for medical devices (classes II and IV).
  • •Manage regulatory documentation integrity and traceability, including document issuance, review, updates, and archiving.
  • •Support regulatory compliance activities, regulatory change monitoring, tecnovigilance/recalls, and preparation for regulatory audits and inspections in Brazil and international manufacturing units.

Pay and Benefits

Perks:Meal AllowanceTravel AllowanceHealth InsurancePensionGym MembershipPaid LeavePet Insurance

Key Requirements

  • •Completed graduation.
  • •Postgraduate specialization in regulatory affairs or related medical/medical devices areas is a plus.
  • •Advanced English.
  • •Intermediate proficiency with Microsoft Office (Pacote Office).
  • •Prior experience in regulatory affairs for medical devices, with knowledge of Anvisa (RDC 665/2022, RDC 751/2022), Inmetro (Portaria 384/2020), and Anatel regulations.
Education:High School
Skills:Regulatory complianceDocumentation managementAttention to detailStakeholder communicationProcess follow-up
Languages:English
Tech Stack:Microsoft OfficeINMETROANATELANVISA

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