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Regulatory Affairs Specialist Stäfa Switzerland,  

Sonova (company)


Posted on : 19 June 2017

Project Description

Description:
  • 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 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!
  • 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 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                                                   


 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.

Locations

Stäfa Switzerland

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