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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. Requirements: Regulatory affairs experience ideally in medical device field for at least 2 years, experience with Class I and II, ISO 13485, FDA you should have both - manufacturing and R&D experience in field of RA Excellent level of English for daily use with consultant, branches in the US and Germany Benefits: salary negotiable 5 weeks of holiday 5 sick days chance to work on highly impactful global medical systems used in hospitals during surgeries Other info: Are you interested in this position? Please fill in the contact form or send us your CV both in English and Czech language with the ref. number in the subject of your application. If you have had an interview in Grafton already, please contact your consultant directly via e-mail. For more related job opportunities visit Please read carefully the text below and attach it to your e-mail/letter. I agree that company Grafton Recruitment, Na Porici 3a, Praha 1, will process my private personal data towards mediation a job (filing, editing, sorting and its providing to a third party whose identity will be communicated to me) in accordance with legislative act number 101/2000 Sb. "O ochraně osobních údajů" until written form revocation. I confirm being awarded of my rights in connection with access to and protection of information. For exact wording of §12 and §21 please go to .
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