QUALITY MANAGEMENT & REGULATORY AFFAIRS MANAGER
ABOUT THE COMPANY
Microbiosensor is an ISO13485 accredited medical device company developing point-of-care IVDs for diagnosing microbial infections and antibiotic sensitivities. Our strategy is to develop simple disposable devices that target high-value market niches, where there is a clear unmet need for improved infection control. The nearest to market application for this technology is an in vitro diagnostic (IVD) for renal dialysis and liver cirrhosis patients. The company anticipates filing a CE mark to permit EU sales for this device in Q1 2022, with an FDA approval to follow shortly afterwards.
THE ROLE Microbiosensor is looking to recruit a Quality Management Systems (QMS) / Regulatory Affairs (RA) manager to help the company maintain and develop its quality management system, compile technical files, and plan and submit documentation to UK, European and US regulatory authorities.
We are looking for a self-motivated and goal-oriented individual who will help coordinate...
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|Posted||September 19, 2021|
|Expiry||October 19, 2021|