Regulatory Affairs Lead – South East of the UK

Moin Din at CK Clinical is recruiting for a Regulatory Affairs Lead – Devices to join a leader in the manufacture and supply of specialty pharmaceuticals at their site based in the South East of the UK.

The Company:

If you are successful for this Regulatory Affairs Lead role you will join an award winning organisation that has been formally recognised as one of the fastest growing companies in 2012.

They are now looking to expand into new and exciting areas and are seeking a well versed and dynamic individual with experience in Regulatory Affairs for medical devices at a national, European and International level to take them to the next stage.

Responsibilities:

As a Regulatory Affairs Lead you will report to the Director of Regulatory and Medical Affairs, as such you will be experienced in class II and class IIIb medical devices.  You will be highly proficient at working with most regulatory bodies and possess good knowledge of CE mark.

This role is not just about existing products, you will also be involved in developments in new areas and on going clinical trials that will form the basis of further expansion and growth and will lead the submission of all new product applications.

  • Be responsible for the maintenance and renewal of CE marks for all Class IIb and III Medical Devices within the company’s existing Business Segments
  • Cross-business expert in Medical Devices from a regulatory perspective, able to shape and assist other functions as they build and strengthen the company medical devices portfolio
  • Maintain and develop CE mark for the company’s wound dressing range – have commercial focus to position the products in the right place in the market
  • Lead the CE mark filing and approval for company’s novel wound care products in Europe
  • Obtain all relevant regulatory approvals for company’s novel wound care products in key International markets.

This role is not just about existing products, you will also be involved in developments in new areas and on going clinical trials that will form the basis of further expansion and growth and will lead the submission of all new product applications.

Qualifications, Skills and Experience:

To be considered for this Regulatory Affairs Lead role, you will have the following qualifications, skills and experience:

  • A full-range of Regulatory experience in class II and IIIb devices
  • Highly proficient at working with most regulatory bodies and possess good knowledge of CE mark.
  • Experience in successful European and International Registration (class IIb and III devices)
  • A strong understanding of the business and commercial awareness.
  • Have experience of managing and maintaining excellent relations with the various Regulatory Authorities in Europe and internationally
  • 6-8 years regulatory experience gained in an international medical devices environment, ideally with experience in wound care
  • A philosophy that sees Regulatory Affairs as a value-adding, integral part of the business, rather than a bureaucratic “necessary” function
  • Accustomed to interacting effectively at all levels within the organisation, as well as with regulatory authorities and external partners/distributors

This is an amazing prospect for the right person seeking their next career move. If you have solid experience in Regulatory affairs class II and IIIb devices, don’t miss this opportunity.

Moin Din - Senior Recruiter at CK ClinicalHow to Apply:

Apply online:

For an informal discussion and further information regarding this Regulatory Affairs Lead role please contact Moin Din in the first instance on +44 (0)207 470 5675 or email on mdin@ckclinical.co.uk.  Please quote reference CL25031 in all correspondence.

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