Luogo di lavoro:Perugia
Nome filiale:FOLIGNO Garibaldi
Numero di candidati ricercati:1
Azienda: Azienda operante nel settore Chimico/Farmaceutico prod ricerca
Our client is an International pharma manufacturer Group.
For their Italian site, located in Umbria region, we are looking for a: REGULATORY AFFAIR OFFICER
to ensure the appropriate licensing, marketing and legal compliance of company products in order to control safety and efficacy.
To ensure that products, which are developed, manufactured or distributed by the company, meet required legislation.
To advise on and coordinate the regulatory approval and registration of company products.
To be the crucial link between the Group and its regulatory authorities, including the:
Medicines and Healthcare products Regulatory Agency (MHRA)
US Food and Drug Administration (FDA)
manage the creation and maintenance of Technical files for the IVD Directive/Regulation
preparation of regulatory submissions for US, Canada, China, Italy and other countries of interest that implement marketing regulations
manage and maintain IVD Device registrations
review all labelling, marketing and training materials for regulatory compliance
provide regulatory input in to product development projects
regulatory input into the complaint handling system
post-market surveillance and vigilance activities
maintain awareness of regulations and guidelines governing the company and communicate their impact on the registrations
authorised to submit regulatory dossiers to regulatory authorities.
Skills & Knowledge
Knowledge and experience of Quality Management Systems, e.g. ISO9001, ISO13485 and the US Quality System Regulation.
Knowledge of regulatory requirements for ISO 13485, IVDD (98/79/EC) and FDA Quality Systems Regulation.
Fluent in English
Qualifications: educated to degree level in life science subject or equivalent qualification/experience.
Experience: experience of preparing regulatory submissions and technical files for medical diagnostic device registrations in key world territories including USA, South America, Middle East, Canada, APAC, BRIC.
Manpower è una compagnia eticamente responsabile. Il servizio è gratuito. I candidati ambosessi (L.903/77 - D.Lgs. n.198/2006) sono invitati a leggere l'informativa Privacy su www.manpower.it Aut. Min. Prot. N. 1116 - SG - del 26/11/04.
Codice annuncio: NT000BA746