Medical Device Risk Management Lead

CK Technical are recruiting for a Medical Device Risk Management Lead to join a company in the biopharmaceutical industry at their site based in Ware on a permanent basis.

The Company:
Our client is an in-house device development group charged with the delivery of robust, patient-centric devices that enable the effective delivery of novel pharmaceuticals.

Location:
This role is located in Ware with the opportunity to work from home when possible (1-2 days per week).

Medical Device Risk Management Lead Role:
Your main duties will be:
- Responsibility for the risk management files for pipeline products.
- Contributing to the development and population of the Design History File.
- Facilitating risk assessments.
- Resolving challenges in design, manufacturing and regulatory affairs.

Your Background:
The ideal candidate for this role will have
- A strong engineering background and a degree in an engineering subject (E.g. Mechanical Engineering, Biomedical Engineering).
- Experience in combination device development.
- Comprehensive understanding of relevant regulations and risk management processes (ISO14791, ISO13485, EU MDR).
- People and project management experience would be very beneficial.

Entitlement to work in the UK is essential. Please quote reference 52366.