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Regulatory Affairs Specialist - Switzerland
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Posted on : 20 March 2017
- 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!
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.
- 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 life cycle
- Update regulatory knowledge with any new developments and ensure the implementation into product development strategy and life-cycle 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
- 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)
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.