Job Description
VALIDATION MANAGER (Medical Devices/IVD/ISO 13485)
Are you an experienced Validation professional?
Experience within an IVD Medical Devices environment working to ISO 13485?
This could be the career progression opportunity you've been looking for!
The chance to become a Validation Manager for a ground-breaking, heavily funded, and fast-growing Medical Devices company is not something that comes up every day……
Our client design, develop and manufacture IVD Medical Devices and are looking to grow their Quality & Regulatory Affairs department by recruiting a Validation Manager, reporting into the VP Quality and Regulatory Affairs.
You will be responsible for providing validation support and oversight of external CMO's, critical manufacturing suppliers and internal development.
The products primary markets will be Low and Middle Income Countries (LMIC) but they will be marketed in higher income countries (HIC) requiring submissions to authorities to include WHO prequalification for IVD's, EU CE-IVD marking and US FDA.
You will lead validation activities and ensure all requirements are laid out in validation protocols.
You will set key validation criteria and specifications, define acceptance test requirements in-conjunction with CMO's, and provide input for product validation requirements.
Skills and Experience:
Strong Validation experience
Experience working with ISO 13485
Experience with Medical Devices/IVD
A relevant life sciences degree is preferred
Able to work in the UK without restriction
Salary: Competitive (dependent on experience)
Permanent contract + Benefits
Location: Newcastle upon Tyne
APPLY NOW! 0161 839 5353 or email Jacob Golding - jacob@emp-sol.com
