Clinical Affairs Manager

vor 6 Monaten

Zurich, Schweiz Sonova AG Vollzeit

Who we are
In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we - through our core business brands Phonak, Unitron, Sennheiser, Advanced Bionics and AudioNova - develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

As Clinical Affairs Manager, you will play a pivotal role in supporting the development and maintenance of clinical evaluation plans and reports. You will be responsible for ensuring all necessary evidence, including literature research and published papers, is obtained to substantiate claims and comply with medical devices regulations. Furthermore, you will collaborate closely with the Sonova Clinical Affairs team, ensuring that clinical evidence remains in alignment with regulatory requirements.

Your tasks
- Define and create comprehensive clinical development plans in collaboration with project and study teams
- Create and maintain clinical evaluation documentation for assigned projects or specific areas within the defined procedure
- Conduct systematic literature research to enhance clinical evidence
- Support the Clinical SOP Owner in keeping procedures and templates up-to-date
- Act as the first-level contact for guiding all departments involved in clinical studies through the process
- Review study request forms and provide support for ethic requests
- Assist with requests to competent authorities
- Ensure quality assurance for all documents related to studies, requests, plans, and reports
- Request, manage, and monitor studies as needed, ensuring adherence to established procedures

**Profile**:

- University degree in Science, Engineering or any related field of study
- Experience in the area of regulatory or clinical trials, preferably in the MedTech industry
- Ability to understand, interpret and explain complex device technical documentation
- Strong communication skills, with the ability to give presentations to a wide spectrum of audiences
- Ability to adapt swiftly in a dynamic, fast-paced environment
- Fluency in English, both written and spoken
- Good MS Office skills

**Offer**:
We can offer you a new challenge, with interesting tasks and much more - including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles. Employment level: 80 - 100%.

Sonova AG
Laubisrütistrasse 28
CH-8712 Stäfa
+41 58 928 01 01

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