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Global Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Altstätten S G
  • Salary: Salary is CHF (Swiss Francs)
  • Job reference: RNMR - CTGS
  • Sector: EPM Scientific, Regulatory
  • Date posted: 30/01/2018
Global Regulatory Affairs Manager

A global leader in dental medical device development is seeking an experienced Regulatory Affairs Specialist who can step into a management position for their site in Altstaetten, St Gallen, Switzerland. This Global Regulatory Affairs Manager will join the regulatory affairs department, currently at 5 people, and be involved in the building out of the dental team for medical devices. This is an incredible opportunity for a senior specialist to be involved with both strategic and operational regulatory activities, with global responsibility. The company themselves operate in the EU, US and Asian markets too. They have continued their exceptional product development and entry into new markets. As a result, after hiring for a  Senior Regulatory Manager in Autumn, will again be investing in regulatory affairs. This is an opportunity for exceptional talent to flourish in a more senior, global role, within a medium sized company where your thoughts and opinions will be valued.

Company Overview

The company itself is a leading member of the global dental device industry. They have an exceptional product pipeline and have internal and external investment for continued regulatory growth in 2018. Their facilities in Europe, the US and Japan are state-of-the-art and they have repeatedly proven their worth against some of the industries giant dental companies. They offer a global opportunity with challenging responsibilities within a medium-sized company. The company places as much emphasis on employee satisfaction as it does on innovation. 

Responsibilities:
  • Develop and implement regulatory strategy
  • Implement and manage regulatory strategies and procedures
  • Perform regulatory and registration activities for EU, US and Asian registrations
  • Provide expertise in applicable regulations in order to identify and suggest potential strategies that can be used to address the gaps
  • Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies
  • Work together with the device development team to define documentation strategy
  • Support implementation of device change in order to assess regulatory implications
 
Requirements:
  • Bachelor’s degree in physical/biological sciences or engineering preferred
  • Expertise in standards and regulations for medical devices in Europe and US
  • Experience with Regulatory Affairs for medical devices
  • Fluent German and English communication skills
  • ISO 13485
 

Package:
  • Unparalleled personal development 
  • Work in the beautiful area of St Gallen
  • Great atmosphere within a vibrant international team
  • A modern and creative working environment, in a medium sized company
  • Insight into cutting-edge technologies for the successful development of dental devices

Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: jobs@epmscientific.com or phone +442037588934
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