BrightOwl Loader Loading

Regulatory Affairs Specialist - Italy  

Company managed [?] Still accepting applications
22 Facebook  Linkedin

Posted on : 01 May 2017

Project Description

Job Scope 
Your Mission  Support the regulatory affairs team in managing the regulatory submission process for IVD products registration at worldwide level    

Main Responsibilities
 Your Contributions   
  • Prepare  registration dossiers to achieve timely regulatory approvals and maintenance of the existing product licenses in international markets 
  • Work closely with product development, marketing and other teams ensuring strategy falls in line with regulatory requirements through the whole product lifecycle 
  • Collaborate in keeping company informed of regulatory requirements in the EU and international markets 
  • Review Change Orders and assess regulatory impact of product changes and manage related submissions Review proposed labeling for compliance with applicable regulations.  
  • Ensure compliance with applicable EU and international law/standards. Support the participation to tenders 
  • Support post-marketing vigilance activities     

Master's Degree: Chemistry, CTF, Biology or equivalent   

Master in Regulatory Affairs   

Preferably 2-3 years experience in a regulatory affairs position in the pharmaceutical, healthcare or medical device/IVD sector.    

Technical Competencies   
  • Knowledge of quality management systems and current International and European regulations with respect of in vitro diagnostics/medical devices    
  • Experience using Microsoft Office programs     

  • Good organizational skills in order to meet the assigned projects 
  • Strong analytical thinking 
  • Good problem solving attitude and understanding of priorities 
  • Effective communication skills and interpersonal skills with sense of responsibility  
  • Ability to work independently and as a part of a team    

Fluent spoken and written Italian and English. Spanish or German is a plus.   

Travel Availability 
 some travel will be required   

We Offer You  As per local and Company requirements