Regulatory Medical Device Consultant

2 weeks ago


Leamington Spa, Warwickshire, United Kingdom Cpl Life Sciences Full time

Regulatory Medical Device Consultant

UK - Fully Remote


An exciting opportunity to work for a well-established Medical Device Consultancy that works with a range of innovative SME and Large manufactures across Europe, with specialisms in software medical devices, cosmetic products, IVD's and more.


As a Regulatory Medical Device Consultant, you will be responsible for providing expert UK/EU/US Medical Device Regulatory advice to a range of clients, including hosting meetings and ensuring the client is satisfied.


Responsibilities
Writing a range of Regulatory Technical documentation.
Previous experience working on the transition from MDD to MDR and fully competent in supporting MDR projects.
Leading projects for a range of clients and happy to speak directly with clients.

  • Supporting a range of projects across the UK, EU, and US.

Requirements:

Degree or equivalent certification in science,medical, or engineering.
4 to 6 years of relevant regulatory experience.
Previous experience working with a range of medical devices (Class 2 and above ideally)
UK, EU, and US experience
Quality Management System - ISO 13485 experience
Risk Management ISO 14971 experience.
Maintain clients UK/CE Technical Files in order to ensure compliance to current


This is an excellent opportunity to work for a well-established regulatory consultancy business that can develop you further within medical devices and give you broader exposure to medical devices.

The role also has the flexibility to be fully remote andcomes with a great salary/ package.

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