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REGULATORY AFFAIRS SENIOR CONSULTANT FOR MEDICAL DEVICES AREA - Italy  

Company managed [?] Still accepting applications

Posted on : 20 February 2017

Project Description


JOB DESCRIPTION:
  •  The resource shall support compliance projects and also bring new expertise in regulatory affairs  for Medical Device area.
  •  He/She will contributes to improve our Medical Device Regulatory  Affairs  team, in order to support our client


MAJOR RESPONSIBILITIES/ACTIVITIES:
  •  Oversee the process of preparing product submissions to domestic and international regulatory bodies and manage the process from inception to approval; 
  •  Interact with FDA, including preparation of PMA/IDE/510K submissions; 
  •  Manage relationship with international Competent Authorities and Regulatory Agencies; 
  •  Plan, review, approve required documents from various departments for filing of required information to Competent Authorities; 
  •  Collaborate with EU and extra EU regulatory to develop global approval strategies; 
  •  Provide regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements; 
  •  Maintain up-to-date knowledge of regulatory requirements; 
  •  Perform audits in Medical Device area; 
  • This position is an excellent opportunity for a motivated individual to contribute to the growth of an immerging life science consulting firm. 
  • You will be rewarded for strong performance and provided opportunities to grow professionally.


Requirements:
  • Fluent English; 
  • Willingness to travel; 
  • Bachelor’s Degree in a life science discipline; 
  • 3+ years experience in Regulatory Affairs or Quality Assurance in Medical Device Industry; 
  • Knowledge of Medical Device requirements (ISO 13485, MDD 93/42, 21 CFR part 820, …); 
  • Knowledge of EU and Extra EU Medical Device Registration Processes; 
  • 510K and PMA Process; 
  • Post Market Surveillance; 
  • V&V Requirements; 
  • Relocation near one of our offices