Consultant Regulatory Affairs IVD

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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 representative 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 Consultant Regulatory Affairs IVD?

  • 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 challenge
    • Hungry for knowledge: You are always open to learning
    • No nonsense mentality: you can be straightforward in a respectful way
    • Innovative: 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’s in it for you?   

  • QbD offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
  • Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed. 
  • As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
  • Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together 
  • Our promise to 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.
    • In short … We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done! 

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family! 

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