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Regulatory Affairs Specialist (maternity leave)

The Italian subsidiary is Distributor of Medical devices and Market Authorisation for Drugs. Responsibilities of the Regulatory Affairs Specialist we are looking for include:

Liaison between business functions and the heads of Pharmacovigilance and RSS

Coordination with RSS and ISF for IMS activities such as transmission of visit data, badges

Management of local activities related to drugs e.g. variations, price increases, promo material and samples

Supporting drug customer tracking and validation activities

For Medical Devices, be the liaison with Manufacture and First Importer in order to keep maintenance of local archive of documentation such as CE certificates, DoCs and datasheets.

Updating of medical device in NSIS system

Review of promotional material

Supporting the tender office

Supporting internal audits

• Regulatory Affairs Specialist (maternity leave)|Biomedical company

Experience and skills:

Working experience in similar position.

Very good knowledge of the reference legislation including Dlgs 219/2006 and MDR 2017/745, MEDDEV reference and Directive 93/42

Proficient in the English language both spoken and written

Native Italian Speaker

Education:

University degree in medicine and surgery or pharmacy or chemistry and pharmaceutical technology or specialist or master's degree belonging to the classes to which the scientific-disciplinary sectors of the above degrees refer, medicine and surgery, pharmacy, chemistry and pharmaceutical technology.

Biomedical company

Ottima opportunit脿 di carriera.