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.
- 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
- salary negotiable
- 5 weeks of holiday
- 5 sick days
- chance to work on highly impactful global medical systems used in hospitals during surgeries
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 www.grafton.cz/en/job-search?disciplines=farmacie-zdravotnictvi
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