Regulatory Affairs Specialist – Medical Devices: dettagli offerta di lavoro
Our client, an important pharmaceutical Company, has charged us to recruit a Regulatory Specialist which has to perform a wide variety of start-up activities integral to the
successful application and acceptance of essential regulatory documents.
For this role is mandatory a fair background in regulatory affairs for Medical Devices products. This professional reports to a QA Manager and liaises with QA dep. for verification of the status of compliance of the implemented QMS vs. FDA mandatory regulations and current guidelines.
One of the main responsabilities is to perform a gap analysis on the existing Technical Files in order to verify their status of compliance to the newest applicable legislation (47/2007/CEE). A proven experience in Risk Management according ISO 14971 would be preferable.
A good knowledge of English language is necessary.
After reading the obligatory information regarding privacy laws on
www.hays.it, we invite you to send your CV in Word, specifying the reference number of the position in question
(Rif. 894586) together with the agreement for access to your personal information, according to the law ex D.LGS. 196/03. Aut. Min. N. 13/I/0007145/03.04 del 1 Aprile 2008.
