Based in Central London this is an exciting opportunity to join an Medical Technology company with a focus in developing Electro / Mechanical Diagnostic Equipment utilising the latest technology, including AI and Computer Vision. The company are currently developing and manufacturing new products for the healthcare sector with commercial activity in UK and Overseas Markets.
The organisation is expanding and looking for a Lead Quality Engineer, preferably with some Regulatory experience, to support and develop their QMS systems and be RA Lead. Responsibilities will include working on MDR and FDA pertaining to Class I and Class II medical devices, leading QMS implementation and maintenance and 510k submissions, although previous experience of this is not a key requirement.
The successful candidate will have a proven background within Quality and Regulatory Affairs for Electro / Mechanical Medical Devices or related industries. Key requirements include:
- Extensive knowledge of ISO13485 and ISO14971
- A strong understanding of MDR and FDA
- Preferably an understanding of Class I and Class II Medical Devices, although knowledge of one would suffice, although a background in Pharma would also be considered
- Strong attention to detail
The company offer a very competitive salary and flexi / home working options.