REGULATORY AFFAIR OFFICER

Azienda

Azienda operante nel settore Chimico/Farmaceutico prod ricerca

Descrizione

Our client is an International pharma manufacturer Group.
For their Italian site, located in Umbria region, we are looking for a: REGULATORY AFFAIR OFFICER

Job Purpose:
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)
China CFDA

Principal Accountabilities:

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.

Luogo di lavoro:

Perugia

Disponibilità:

Tipologia:

Full Time

Data pubblicazione:

19/09/2017

Codice annuncio:

500194999

Visualizzazioni annuncio:

422

Nome filiale:

FOLIGNO Garibaldi

Numero di candidati ricercati:

1
NOTE LEGALI:
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.

REGULATORY AFFAIR OFFICER

Perugia
Full Time
19/09/2017
500194999
422
FOLIGNO Garibaldi
1

Azienda

Azienda operante nel settore Chimico/Farmaceutico prod ricerca

Descrizione

Our client is an International pharma manufacturer Group.
For their Italian site, located in Umbria region, we are looking for a: REGULATORY AFFAIR OFFICER

Job Purpose:
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)
China CFDA

Principal Accountabilities:

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.
NOTE LEGALI:
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.