Clinical Affairs Manager (m/f/d)

Sonova
Switzerland
Workplace: HybridFull timeFunction: Data Science & Machine LearningEducation: mastersSkills: ["Analytical skills","Attention to detail","Independent ownership","Collaboration","Communication"]

Support the clinical evaluation of hearing instrument systems across the product lifecycle to enable market access and ensure compliance with clinical regulations. Plan and critically appraise clinical and scientific evidence, assess safety and benefit–risk, and produce clinical evaluation documentation (plans, reports, and post-market follow-up) in collaboration with cross-functional teams. Provide regulatory guidance for product claims and help drive regulatory compliance, knowledge sharing, and continuous improvement.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
Sonova
Sonova
1 day ago

Clinical Affairs Manager (m/f/d)

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI
Last checked: 10 hours agoStatus: Live

Job Summary

Support the clinical evaluation of hearing instrument systems across the product lifecycle to enable market access and ensure compliance with clinical regulations. Plan and critically appraise clinical and scientific evidence, assess safety and benefit–risk, and produce clinical evaluation documentation (plans, reports, and post-market follow-up) in collaboration with cross-functional teams. Provide regulatory guidance for product claims and help drive regulatory compliance, knowledge sharing, and continuous improvement.
Location: Switzerland
Workplace: Hybrid
Employment Type: Full time
Job Function: Data Science & Machine Learning

Key Responsibilities

  • •Support clinical evaluations of hearing instruments throughout the product lifecycle, from early development through market launch and post-market activities, per Sonova procedures and global regulations.
  • •Plan and scope clinical evaluations; identify, critically appraise, and analyze relevant clinical and scientific data.
  • •Assess device safety, clinical performance, and the benefit–risk profile against the current state of the art.
  • •Create and maintain clinical evaluation documentation with cross-functional teams, including Clinical Evaluation Plans/Reports and Post-Market Clinical Follow-up Plans/Reports.
  • •Collaborate with Clinical Affairs, Clinical Operations, Audiology Research Centers, R&D, Regulatory Affairs, Quality, and Marketing to ensure regulatory compliance and continuous process improvement.

Key Requirements

  • •Master’s degree or PhD in health sciences, audiology, medicine, biomedical engineering, psychology, life sciences or a related field.
  • •Experience conducting, coordinating, or monitoring clinical studies or investigations.
  • •Experience working with clinical data and critically interpreting clinical study results, scientific publications, and statistical analyses.
  • •Ability to conduct scientific literature searches (e.g., PubMed, Cochrane, Embase) and critically appraise and summarize evidence.
  • •Knowledge of clinical/medical-device regulations and standards such as EU MDR, FDA requirements, GCP, or ISO 14155.
Experience:Medical-device industryAudiologyHearing instruments
Education:Master's
Skills:Analytical skillsAttention to detailIndependent ownershipCollaborationCommunication
Languages:EnglishGerman
Tech Stack:PubMedCochraneEmbasePolarion

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