Regulatory Affairs Specialist - Switzerland
- 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 – develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.
- Our company has more than 13,000 committed employees in over 90 countries, all of whom contribute to something greater than themselves – they transform lives.
- Join our mission and become part of our team!
- In this position, you will be responsible for the notification and evaluation of incidents and adverse event reports.
- Additionally, you are supporting the Regulatory and Clinical Affairs team.
- Ensure accurate and timely reporting to authorities in compliance to SOP`s, MEDDEVs, ISO 14155, 93/42/EEC and international and local laws for medical device adverse event reporting and vigilance reporting Maintain country specific adverse event and vigilance requirements
- Create responses to general requests/queries regarding vigilance and reporting
- Support the submission related activities for new and ongoing product submissions
- Bachelor degree Minimum 3 years’ experience in Regulatory Affairs
- Detail-oriented person with experience in working in a highly regulated environment
- Excellent interpersonal communication (oral and written) Ability to work in an interdisciplinary team
- Fluent in German and English
- 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.