Senior Regulatory Affairs Consultant

England Permanent
  • Opportunity to be a part of a growing UK business
  • Responsible for leading client projects and providing expert Regulatory support

About Our Client

My client is a UK Regulatory Affairs consultancy, rapidly growing and specialize within Medical Devices & IVD Regulations.

Job Description

  • Provide consultation on regulatory standards, directives, regulations and statutory frameworks as applicable to our customers
  • Write documentation including Technical Files, regulatory submissions, reports and documents as required for regulatory compliance of Customer's products
  • Conduct gap assessments of client documentation against regulatory requirements such as MDR / IVDR
  • Provide consultation on guidance documents published by regulators
  • Plan and deliver public and in-house training courses at various locations in the UK in relation to regulatory and quality standards and issues of the industry
  • Work within customer led deadlines
  • Attend training to encourage multiskilled, more rounded consultants within the role
  • Regular and accurate reporting on status of client projects
  • Fulfilling company admin requirements

The Successful Applicant

  • At least five years' experience within IVD/Medical Devices through positions in industry, consultancy or regulatory agencies (FDA, Notified Body etc)
  • Experience of Global registrations such as 510ks, PMA's, TGA, etc.
  • Some quality experience would be advantageous
  • Remote position but occasionally required to travel as and when required to head office and clients sites
  • Genuine interest in regulations and client businesses
  • Proactive team player

What's on Offer

Remote based working

Competitive package and benefits

Opportunity to be a part of a growing UK Business

Kelly Percival
Quote job ref
Phone number
+44 1727 730 143

Job summary

Contract type
Consultant name
Kelly Percival
Consultant phone
+44 1727 730 143
Job reference