Regulatory Affairs

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Regulatory Affairs

One of our core focuses 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.
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.
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.
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.