• Reference: 00084352
• Salary: £35k+
• Location: Hertfordshire – will relocate 

This exceptional candidate is a highly organised QMS auditor and Regulatory affairs management professional who has an MSc in Biomedical Sciences. They have extensive knowledge of FDA, MHRA and EMEA regulations and broad experience and compliance with Medicinal Products and Devices 21 CFR part 807, 812, 814, 820 and ISO-14155, ISO-13485. This candidate is currently working for a major medical device manufacturer as Regulatory Affairs Compliance Specialist.

Their main responsibilities include providing assistance with regulatory approval of new products and updates of approval of existing products.  Other duties include handling regulatory submission packs for the regulatory authorities. Prior to this role this candidate worked as a Biomedical Scientist, working in Regulatory and Quality. Through their experiences they have gained excellent knowledge in validation and sterilization methods. This candidate  has their own transport and is available for work on a weeks notice.

For more information please contact Naynesh Mistry on 0114 283 9956 or email nmistry@ckscience.co.uk

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