Clinical Affairs Manager (m/f/d)

Sonova Group; Genf, Stäfa; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Sonova Group is seeking a dedicated Clinical Affairs Manager to support clinical evaluation of hearing instrument systems and market access alignment in a regulated environment.

The role requires a master’s or PhD in health sciences or related field, experience with clinical studies, and strong analytical skills. Fluent English is required; German is a plus. This is a hybrid role in Switzerland with cross-functional collaboration across R&D, regulatory, and QA teams.

Qualifikationen

• Masters or PhD in health sciences or related field.
• Experience with clinical studies and data interpretation.
• Knowledge of EU MDR, FDA, GCP, ISO 14155.
• Strong analytical and detail-oriented mindset.
• Fluency in English; German a plus.

Aufgaben

• Support clinical evaluations across the product lifecycle in line with company procedures and global regulations.
• Create and maintain clinical evaluation documentation (CE Plans/Reports, Development Plans, literature search plans).
• Assess device safety, performance and benefit–risk against current standards.
• Collaborate with Clinical Affairs, Regulatory, Quality and Marketing to ensure compliance.

Kenntnisse

Analytical skills

Independent working

Cross-functional collaboration

English fluency

German knowledge (advantage)

Ausbildung

Master's degree or PhD in health sciences or related field

Tools

PubMed

Cochrane Library

Embase

Polarion

Jobbeschreibung

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At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

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.

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.

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.