Description
I am currently recruiting for a Senior Regulatory Affairs consultant on a long term contract 12-15 months. The role is office based in Sussex and they will allow one day home working.This Medical Device client is building a brand new Global Headquarters and flagship manufacturing facility, and need an ambitious and highly motivated Regulatory Affairs Professional to manage the international registration activities for transferring to a new facility.
You will be working with our QA/RA, Operations, R&D and Commercial departments to finalise and execute a regulatory facility transition plan and to ensure the timely approval of licences and facility approval in all our international markets.
This is an exciting opportunity to make a major contribution to a growing class III medical device manufacturing facility. You will be fully involved from early design phase right through to final sign off of the new facility.
Essential:
* Degree in Science/ Engineering or equivalent professional experience
* Experience in management of complex regulatory projects
* 3- 5 years regulatory affairs and international registration submissions experience, including the hosting of audits and inspections
* Solid working knowledge of cGMP, FDA 21 CFR Part 820 Quality Systems Regulation and related regulations, European Medical Device Directives and ISO 13845 Medical Device Quality Management Systems
* Experience with, and knowledge of, other ROW regulatory agencies
* Excellent communication skills
Desirable:
* Previous experience in the successful transfer of a manufacturing facility
* Project Management qualification - APMP, PRINCE2 or similar
If you are interested in this role please respond ASAP with an updated CV and your location and availability to start and to interview.
Please pass this on to friends or colleagues as we offer referral vouchers.
Kind regards,
Nathan Puxty