Regulatory Affairs Specialist

Overview

Sentinel Diagnostics, leader in the Development and Production of Diagnostic Kits for Clinical Chemistry, Immunology, Molecular Biology, Chromatography and Rapid Test, in order to expand the Regulatory Affairs Team, is looking for a :

REGULATORY AFFAIRS SPECIALIST

Responsibilities

• Definition of regulatory strategies for global market access of In Vitro Diagnostic medical devices, in accordance with the company priorities
• Preparation and submission of the mandatory technical and legal documentation files for worldwide product registration approvals, including the European and US markets
• Collaboration with distributors Regulatory Affairs functions
• Monitoring of the new international applicable requirements in order to support the company business
• Continuous maintenance of the products conformity to applicable laws, regulations, guidelines and international standards
• Participation in corporate projects in order to provide regulatory guidance to cross-functional teams

Requirements

• Scientific Degree
• At least 3 / 4 years of experience in similar role within the Medical Device / IVD sector, possibly in an international context
• Excellent knowledge of national and international regulatory regulations (ISO 13485, ISO 9001, MDSAP, IVDR 746 / 2017, US FDA 21 CFR)
• Good knowledge of the regulatory management of In Vitro Diagnostic Medical Devices (IVD)
• Any additional knowledge of the regulatory management of In Vitro Diagnostic Medical Devices (MDCG Guidelines, Anvisa, Health Canada, 510K) will be a preferential requirement
• Fluent in English
• Ability to interact with the different teams in the organization
• Capacity to meet deadlines and focus on priorities
• Proactivity and autonomy
• Motivation and enthusiasm

Location

Location : Milan (Lorenteggio)

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