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Regulatory Affairs

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Regulatory Affairs

Our one and only focus in the Medical Technology Industry.

We can appreciate the regulatory pressures and how business-critical your role is to an organisation. Our recruitment consultants deep-dive into the regulatory topics to ensure was can have an in-depth understanding of CE-marking, MDR/IVDR registrations, technical documentation, notified bodies, PMS, and vigilance.


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    CE-marking and Product Registrations




    • Whether you are bringing a new device to market or overseeing the transition to new regulations, our consultants understand the different classes of device from I - III and the working relationship with Notified Bodies, country authorities and compliance with applicable regulations like MDR, IVDR and FDA.


    • Talk to us about the lifecycle of the device and if you are specialized in a particular area or covering the broad spectrum from clinical to PMCF.
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    Auditing



    • We understand the difference between ISO13485 and MDSAP, MDR and IVDR, IEC 62304 and EN 60601.


    • We support candidates who have auditing as a small part of their role in regulatory, or when most of their focus is on correspondence with NBs and competent authorities across different markets.
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    Notified Bodies


    • We build close relationships with prestigious Notified Bodies who are designated under MDR and IVDR and offer a wide range of possibilities, from becoming a Technical Specialist focused on a particular active/non-active product portfolio, to auditing of medical manufacturers.


    • Our consultants can advise you on the best route to take in order to 'make it' on the other side of regulatory.
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    Technical Documentation


    • Our team in regulatory affairs recruitment spend a lot of their day talking to candidates about the technical file!


    • We know the level of inter-disciplinary work needed between departments like R&D and Quality, the volume of clinical data and CERs, intended use, usability and the documentation required to ensure devices are compliant and keep their certification.

Watch our video to learn about our recruitment expertise in Regulatory Affairs



Regulatory Affairs Jobs