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REGULATORY AND QUALITY SPECIALIST

Job description Person at this role will be responsible for supporting and maintaining mostly regulatory but also quality assurance processes and requirements according ISO 13485 and FDA in R&D medical device company based in Brno, coming from the USA. work according Medical Devices Directive and FDA compliance of Class I and Class II products and its documentation setting SOP/WI and other procedures communication with external consultants and advisory companies in terms of certifications, etc.
 
 
 
 
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