Regulatory Affairs Consultant IVD
il y a 1 mois
Table of Contents
Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations.
Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. We help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). We’re also authorized representatives for non-EU manufacturers and offer a unique solution for e-labeling, currently used by multi-billion-dollar medical device and IVD companies all over the world.
What do we expect from you as a Regulatory Affairs Consultant?
You are a thought leader in the field of EU and preferably also in non-EU Quality Systems & Regulatory Affairs consulting for In Vitro Diagnostics (IVD) industry. You provide a full range of quality and regulatory consulting services in the development, registration and post-licensing activities of In Vitro Diagnostics (IVD). You act as a Regulatory intelligence expert , for internal as well as external stakeholders. You manage activities with minimal supervision and in an independent manner. You have a commercial touch and interact professionally at multiple levels within a client organization.
Who are we looking for?
You have a university degree in life science and significant quality and regulatory affairs experience within the field of IVDs. You have in depth knowledge of regulation for IVDs (21 CFR 820 & EUIVDR 2017-746), quality management system (ISO 13485), technical standard applicable to in vitro diagnostic medical devices and software used for Medical Devices (IEC 62304) You have excellent written skills and represent complex issues in a clear manner. You have excellent verbal communication skills and can establish strong connections with clients, regulators, management and colleagues. You thrive in an international environment. You like travelling and attending conferences . You enjoy giving presentations and providing trainings all over the globe. You are comfortable to present work-related topics in front of a public. You are very fluent in English . Fluency in two other EU languages is a strong plus. You have good organisational skills and an analytical mindset. A true QbD’er can be recognized by the following qualities: Resilient: Your strong and positive attitude helps you overcome any challengeHungry for knowledge: You are always open to learningNo nonsense mentality: you can be straightforward in a respectful wayInnovative: You are constantly looking for new and better solutions(Not too) serious: your job is serious, but you don’t take yourself too seriously.
What does QbD Group offer you?
As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
Even more, we offer:
Room to shape and implement your strategic regulatory stamp and have impact A full-time and long-term commitment A sustainable career filled with meaningful connections on international level within a knowledge-based companyIn short… We go and stand for JPEG : J oy in P artnership, going for the E xtra mile to G et things done
Interested?
Send us your CV and motivation letter and who knows, maybe you’ll find your #QbDream job.
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