Consultant - Regulatory Affairs

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