About the Role:
I'm partnering a Medical Device organisation to secure a Senior Regulatory Affairs Specialist and a Regulatory Affairs Specialist to be based in the Warwick area.
It is imperative that you have an exceptional understanding of the Medical Device industry and have worked on a variety of Medical Devices, ideally from Class I-III.
It would be beneficial if you had experience with the FDA including the compilation of 510(k) submissions and 21 CFR 820.
- Preparing, reviewing and approving data elements for use in regulatory technical files in accordance with EU requirements for medical devices and IVD's.
- Providing on-going regulatory advice and guidance, in an expert capacity, to all clients and junior members of the team.
- Liaising with external regulatory authorities to ensure approvals are obtained in line with project schedules.
- Performing all activities in compliance with relevant Quality Systems standards and specifically with ISO 13485.
The salary range depends on the level of experience.
If this sounds like an interesting prospect, please contact Lillie Fenlon-Billson at Real Staffing on [... Click Apply...]311 or l.fenlon-billson at [... Click Apply...]
Sthree UK is acting as an Employment Agency in relation to this vacancy.