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REGULATORY AFFAIRS SENIOR CONSULTANT FOR MEDICAL DEVICES AREA Milan Italy,  


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 (Milan, Reggello, Mirandola);

Locations

20124 Milano Italy

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