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Regulatory Affairs Manager - Medical Devices - Zürich, Switzerland Nr ref.: /JOBS.pl As the Regulatory Affairs Manager you will be involved with the International Registrations of a portfolio of medical device products across Europe. If you are looking for an exciting forward thinking company, where you can put your expertise in creating strategies and implementation of clinical plans to good use, travel extensively and be instrumental in driving forward the mission to improve peoples lives, then this is the job for you! Role responsibilities You will ensure that documentation for submissions on an International basis are prepared in a timely fashion. You will be the first point of contact with the local health authorities, notified body and any other approving bodies. You will maintain international product licences Providing support when external audits are being undertaken Train staff from other disciplines to ensure the regulatory requirements are understood and followed Your profile You should have at least 2 years experience working within the Regulatory function of an EU based Medical Device Company. Ideally experienced at obtaining CE-mark and FDA approvals. An understanding of Quality System requirements according to standards such as ISO13485:2016 is desirable Fluent in spoken and written English is a must, any additional language an advantage (German, French or Italian) You should be educated to at least degree level in Life Sciences or a related subject. Must be competent in determining the appropriate global regulatory requirements for new products or product changes. Must have strong written and verbal communication skills and have experience working on cross-functional project teams. For more information or a confidential discussion about this position please contact Darren Hall either by telephone on or email me on Darren.hall tecgroup.net including a copy of your CV in English and supporting documents. Due to the volume of applications for this position if you have not received a response within 5 working days then unfortunately on this occasion you have not been successful but we will consider you for other positions that may be suitable. Keywords: Regulatory Affairs, Reg Affairs, French, German, Switzerland, class III, Class 3, medical device, FDA, CE, vigilance, compliance. REG AFFAIRS, Medical Devices, REG AFFAIRS, Regulatory Affairs Manager, RA Manager , RA Manager, Medical Devices, REG AFFAIRS, Regulatory Affairs Manager, RA Manager , RA Manager, Medical Devices, REG AFFAIRS, Regulatory Affairs Manager, RA Manager , RA Manager, Medical Devices, REG AFFAIRS, Regulatory Affairs Manager, RA Manager , RA Manager, Medical Devices, REG AFFAIRS Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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