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Regulatory Affairs Manager EMEA & APAC - Switzerland  

Company managed [?] Still accepting applications
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Posted on : 10 February 2017

Project Description

 About Us:
  • People at our company appreciate the opportunity to shape our future and create impact.
  •  Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations.
  •  In your role as a passionate and performance driven Regulatory Affairs Manager you will be responsible for the overall product registration strategies, coordination, implementation, execution, control and completion of product registrations world-wide except US. 


Your tasks: 
 
  • Preparing the Technical File for international registrations 
  • Registration of the new products world -wide except US 
  • Product lifecycle management and product license maintenance 
  • Set up registration strategies; execute registration process from  dossier compiling to submission and approvals of assigned products throughout  various regions

       
Your profile: 

  • University degree in a scientific discipline such as biology ,  pharmacy, chemistry, engineering or equivalent 
  • 5 years’ experience in General Regulatory Affairs, with at least 2  years of international regulatory experience 
  • Profound experience with international medical device (class II &  III) regulatory approvals and submissions 
  • Proven track record of successful interactions with Health  Authorities 
  • Excellent command of spoken and written English; any other language is  an asset  
  • Effective communication and persuasion skills to interact across  different levels and cultures 
  • Results-oriented in a dynamic environment 
  • Agility to handle and deliver on a multitude of projects, programs,  and priorities paired with high sense for execution and teamwork 
  • Accountable personality with a structured and pragmatic working  style 
  • Ability to build trust and drive engagements in others in a constantly  changing environment 
  • Collaborative, emphatic and solution oriented  individual