Regulatory Affairs Specialist

Sentinel Diagnostics; Vicenza; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading diagnostics company in Milan is seeking a Regulatory Affairs Specialist to define regulatory strategies and ensure compliance for the global market access of their In Vitro Diagnostic medical devices. The ideal candidate will have a scientific degree and at least 3-4 years of experience in a similar role within the Medical Device/IVD sector, with excellent knowledge of regulatory requirements and fluency in English.

Competenze

• At least 3-4 years of experience in a similar role within the Medical Device/IVD sector.
• Excellent understanding of ISO standards and FDA regulations.
• Ability to maintain compliance with international regulations.

Mansioni

• Define regulatory strategies for global market access.
• Prepare and submit documentation for product registration approvals.
• Monitor international regulatory requirements and maintain compliance.

Conoscenze

Knowledge of regulatory requirements

Fluent in English

Scientific knowledge

Ability to interact with teams

Proactivity

Formazione

Scientific Degree

Descrizione del lavoro

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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