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Regulatory Affairs Specialist

Inseriert am: 18.07.2019








































In a life without sound, our work provides meaning. As the world’s leading hearing care provider, 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 brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova – develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

Sonova has more than 14,000 committed employees in over 100 countries, all of whom contribute to something greater than themselves – they transform lives. Join our mission and become part of our team! Apply now for the following position:
Sonova / Switzerland / Stäfa
Regulatory Affairs Specialist
In this position, you will support our Regulatory Affairs team in the building of documentation dossiers to achieve timely regulatory approvals and maintenance of the existing portfolio.

Your tasks


  • Preparation of documentation dossiers to achieve timely regulatory approvals and maintenance of the existing portfolio

  • Key contact and support for distributors and affiliates for global submission efforts

  • Work closely with product development, marketing and other teams ensuring strategy falls in line with regulatory requirements through the whole product lifecycle

  • Update regulatory knowledge with any new developments and ensure the implementation into product development strategy and lifecycle efforts

  • Provide guidance on the approval process through EU, US and other markets

  • Propose process improvements and share best practice involving international regulatory submissions

  • Support post market surveillance activities including complaint reporting and post market vigilance systems

Your profile


  • Bachelor degree in Science or equivalent

  • Minimum 2 years’ experience in a regulatory affairs position in medical device area

  • Strong analytical thinking and understanding of international regulatory landscape & required approaches (eg. USA FDA, Canada, EU)

  • Solution-driven person who likes to work independently

  • Effective communication and interpersonal skills with sense of responsibility

  • Team player and enthusiastic individual with drive

  • Fluent in German and English (spoken and written)

Our 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.

Lena Hüster, Human Resources Specialist, is looking forward to receiving your complete application (cover letter, CV, references and certificates) via our online job application platform.

For this vacancy only direct applications will be considered.
Sonova AG
Laubisrütistrasse 28
CH-8712 Stäfa
+41 58 928 01 01
Create impact. Transform lives – sonova.com/careers





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