Description
EXPERIENCE* Degree in scientific discipline
* Minimum 2 years quality and regulatory experience preferably gained
working in a Medical Device business
* Experience implementing Quality Systems to ISO 9001 and ISO 13485
standards, and within other regulatory frameworks, including EU MDD,
UK and US FDA
* Authoring of Quality System SOPs and Forms.
* Proven knowledge of 21 CFR Part 820 and Part 11 requirements.
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