About this role
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. More about what we offer: As one of the world’s leading hearing care providers headquartered in Switzerland, we are committed to building an inclusive culture where you can balance a successful career with your life outside of work through our flexible hybrid working model. We offer a wide range of training opportunities for both professional and personal development, with strong growth opportunities supported by individual development plans. Application process: Magdalena Suszek, Talent Acquisition Partner, is looking forward to receiving your application via our online job application platform, including your CV and cover letter. For this vacancy, only direct applications will be considered.