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Head Regulatory Affairs Projects & Alliances - Switzerland  

Company managed [?] Still accepting applications

Posted on : 26 January 2017

Project Description

 
About us :
  • We are a global leader in implant, restorative and regenerative dentistry.
  • We offer our products and services to dental professionals and dental laboratories around the world. 
  • Our aim is to partner with passionate people who fit in with the agile dynamics of our size-for-success company. 
  • 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.
  • For our RA Projects & Alliances team we are currently looking for a Head Regulatory Affairs to represent and promote company ’s interests to various government officials and regulatory agencies focusing on BRIC countries. 
  • Acting as Head RA Projects & Alliances you will work closely with our VP Corporate QA/RA in representing our company  during Alliances’ activity.


Your tasks  
  • Collaborate with our global marketing team (Customer Solutions &  Education) to plan and coordinate regulatory strategy and submissions and  support on going and future submissions for IRA 
  • Work closely with Business Development to plan and coordinate  regulatory strategy and projects 
  • Partner with Instradent (Instradent is part of the company Group and  acts as a business platform to drive and manage the distribution and  internationalization of brands for tooth replacement solutions such as dental  implants and prosthetics) to plan and coordinate regulatory strategy and  submissions 
  • Monitor the regulatory environment globally and provide assessments of  the impact of new and changing regulations  
  • Have a deep understanding of policy development, regulatory processes,  and contacts, with a particular focus on BRIC 
  • Direct and coordinate activities concerned with the submission and  approval products to government regulatory agencies 
  • Provide guidance to project team members regarding regulatory  compliance issues 
  • Oversee the preparation and maintenance of regulatory submissions and  files for IRA 
  • Establish accountability for preparation of necessary outlines,  summaries, status reports, charts and slides 
  • Provide overall management of the Regulatory staff development and  budget to support business objectives 
  • Collaborate with the management team in establishing short and long  term strategic goals and direct implementation to achieve objectives 
  • Drive learning initiatives and training of RD&O employees on  current and emerging regulatory and related requirements 
  • Develop and monitor appropriate metrics to track quality / regulatory  and process improvement

     

Your profile 
  • Undergraduate degree in related field, advanced graduate studies  preferred 
  • 8+ years’ international expertise in Quality Assurance and Regulatory Affairs  
  • Significant experience in medical device Quality and Regulatory  management 
  • Profound know-how of Class II and III medical devices 
  • Expert understanding of medical device regulations 
  • Management experience highly desired 
  • Fluent English, any other language an asset 
  • Ability to deliver high complex information in a clear, structured,  and compelling manner both to a technical and non-technical audience 
  • Inspiring personality, able to present to and engage a large audience  and build effective relationships 
  • Deliver what you promise, tackle challenges and go for it – with  passion! 
  • Embrace change and adapt proactively, showing a “can-do” attitude 
  • Dedicated to developing an organizational culture that promotes and  sustains quality and regulatory affairs as an element of excellent business  performance