I Am looking for a Regulatory Affairs Contractor for a Client Based in York, to come in as the RA Lead reporting into the QA RA Director for a 6 month Contract, potential to extend for 18 months The Project is a Full new product development for a Lateral flow Assay and Reader Software.
On this project you will be working closely with the R&D team and the project team so will be required to be on site in York. The Client can offer 3-5 day contracts.
START Date is 6/05/2019
Successful candidates Must have:
- Understanding of Pre submission process for 510k's
- Written Clinical Protocols and SOP's or have a good understanding of Clinical trails in the USA
- Worked Autonomously
- Ability to Lead the RA efforts on an Exciting new product.
If you have experience with 510K Submissions for Medical devices not IVD's I would still be very keen to speak to you Please email me an up to date copy of your CV and a convenient time to call you
To find out more about Real please visit www.realstaffing.com
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