IVD Regulatory Affairs Specialist

Job Reference: #11368 Add to saved jobs

  • Location United Kingdom, North, North West, North East
  • Contract
  • Sector Medical Devices

Job Summary

Meet are collaborating with an IVD Company in the North who are looking for an interim Regulatory Affairs Specialist to join during an exciting time for the organisation.

Job Overview

IVD Regulatory Affairs Specialist

My client has an innovative Device which they are aiming to be CE marked within the third quarter of 2017.

I am looking for contractors with in depth experience in reviewing, updating & developing IVD Technical Files within tight deadlines.

Reporting to the Quality Assurance & Regulatory Affairs Manager, the main duties of the IVD Regulatory Affairs Specialist will be:

• Liaising with SME’s to extract information needed for Technical Files

• Ensuring all information is prepared & in line with company processes

• Constant liaison with external Notified Body representatives

• Ensuring Regulatory compliance is at an exemplary level across the organisation

• Constant development, review & updating of technical files in preparation for Notified Body audit

Requirements for the IVD Regulatory Affairs Specialist:

• In depth experience within IVD companies/environments

• Proven background in preparing Technical Files for CE Marking

• Experience working with Annex II List A IVD devices

• Experience of overseas markets

• Proven relationship building experience with external parties

If you are immediately available & interested in this post, please submit your CV or call Rob McCarry at MEET Recruitment on 0203 019 6003.

Skills Required

• In depth experience within IVD companies/environments

• Proven background in preparing Technical Files for CE Marking

• Experience working with Annex II List A IVD devices

• Experience of overseas markets

• Proven relationship building experience with external parties

• Excellent team player

Contact Details

Rob McCarry
Phone: 0203 019 6003
Email: rob@peoplewithchemistry.com

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