Clinical Affairs Manager (m/f/d)

Sonova is seeking a dedicated and detail-oriented Clinical Affairs Manager to support the clinical evaluation of our innovative hearing instrument systems. As a Clinical Affairs Manager, you will play a crucial role in supporting the market access of our medical devices in ensuring compliance with company procedures and applicable clinical regulations. This position requires a strong understanding of clinical data and the ability to summarize relevant clinical evidence effectively according to a pre-defined plan. 

More about the role:

• Support clinical evaluations for hearing instruments throughout the product lifecycle—from early product development through market launch and post-market activities—in accordance with Sonova procedures and applicable global regulations.


• Plan and scope clinical evaluations; identify, critically appraise and analyze relevant clinical and scientific data.


• Assess device safety, clinical performance and benefit–risk profile against the current state of the art.


• Create and maintain clinical evaluation documentation in collaboration with cross-functional project teams, including Clinical Evaluation Plans and Reports, Clinical Development Plans, scientific literature search plans and reports, and Post-Market Clinical Follow-up Plan and Reports.


• Support  with  regulatory guidance for product claims.


• Collaborate closely with Clinical Affairs, Clinical Operations, Audiology Research Centers, R&D, Regulatory Affairs, Quality and Marketing to ensure regulatory compliance, knowledge sharing and continuous process improvement.

More about you:

Must-have:

• A master’s degree or PhD in health sciences, audiology, medicine, biomedical engineering, psychology, life sciences or a related field.


• Experience working with clinical studies or investigations, for example conducting, coordinating or monitoring clinical studies.


• Experience working with clinical data and the ability to critically interpret clinical study results, scientific publications and relevant statistical analyses.


• Experience conducting scientific literature searches using databases such as PubMed, Cochrane or Embase, as well as critically appraising and summarizing the identified evidence.


• Knowledge of relevant clinical and medical-device regulations and standards, such as EU MDR, FDA requirements, GCP or ISO 14155.


• Strong analytical skills and attention to detail.


• Ability to work independently, take ownership and manage responsibilities and deadlines effectively.


• A collaborative, self-motivated approach and the ability to communicate openly and effectively across interdisciplinary teams.


• Fluency in English is required; knowledge of German would be an advantage. 

Nice to have

• Hands-on experience conducting Clinical Evaluations in accordance with EU MDR.


• Experience within the medical-device industry.


• Experience with hearing instruments, audiology or another relevant healthcare product area.


• Knowledge of Polarion or a comparable documentation management system.