Regulatory Affairs Director - IVD - Cambridgeshire

This vacancy is now closed
Market leading salary package - IVD Class - Regulatory Affairs
Ref: 6 Date Posted: Thursday 06 Jun 2019
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Our client is a leading international IVD company with offices in UK, USA, South America, EU, Asia and Australia.

 

They continue to invest in building a strong regulatory affairs function focused on the EU market and have created a new position for a RA Director / Regulatory Affairs Director to join their Cambridge office.

 

This is an excellent opportunity to join a diagnostic specialist that offers an excellent career platform and top salary packages for high calibre professionals.

 

Our client offers an excellent opportunity to develop an EU focused regulatory team.

                      

If you are a RA / Regulatory Affairs professional who possesses in depth experience within IVD or Medical Device product registrations for EU and can lead a Regulatory Team, please apply today or contact the team at Indo Professionals for more information.

 

josh@indoprofessionals.co.uk / 01256 597 800

 

Position:

Regulatory Affairs Director – IVD Product registrations

 

Location:

Cambridge

 

Salary:

Industry leading salary package including shares, bonus, pension and healthcare

 

Job role:

The primary focus of this Regulatory Affairs Director position is to support product registration for sale in EU. Core responsibilities include:

  • Lead and manage a team of EU focused regulatory professionals
  • Development of product regulatory compliance strategies for EU market
  • Provision of regulatory advice and guidance to leadership and support functions
  • Work with product development teams
  • Develop and maintain registration documents
  • Develop working procedures for process improvement
  • Provision of regulatory training
  • Assist in preparation for internal audits
  • Assist in external audits

 

Experience required:

Our client is looking for a senior level Regulatory Affairs professionals with experience of developing a regulatory function and thorough IVD / Medical Device product registrations experience. Further experience required includes:

  • Degree level education or equivalent working experience within IVD / Med Tech
  • Experience of product registrations for EU IVD or Medical Device market – essential
  • Excellent team management / leadership skills
  • Excellent communication, presentation and influencing skills
  • Experience within a commercially focused role

 

Indo Professionals is a specialist medical device staffing business focused on placing high calibre professionals into regulatory affairs, quality assurance and clinical research positions UK wide. If you are looking for a new career challenge or would like a career consultation with an industry expert, please contact the team today.