SENIOR QUALITY & REGULATORY OFFICER (Quality Assurance / Regulatory Affairs)
Quality Assurance professional? Regulatory Affairs professional? Both!?
We have an opportunity to join a fast growing, exciting, heavily funded, diagnostics company as a Senior QA/RA Officer.
The QA/RA Officer will develop, revise and implement Quality procedures and policies for the company. This will include working toward ISO 13485:2016, in compliance with BS EN ISO 14971:2012, assistING software developers to IEC 62304, ensuring Regulatory compliance and working closely with Regulatory Managers.
You will be responsible for planning, undertaking and recording the validation of QMS related software packages.
You will conduct internal quality system audits and external vendor assurance audits.
You will maintain QMS, Q-Pulse including monitoring and progression of CAPA and audit actions.
You will work to ensure that Quality compliance targets are met.
Skills and Experience:
Strong Quality or Regulatory experience
Experience working with ISO 13485, ISO 14971 and/or IEC 62304.
Experience with Medical Devices/IVD
A relevant life sciences degree
Experience of software validation
Able to work in the UK without restriction
Salary: circa £35k (dependent on experience)
Permanent contract + Benefits
Location: Newcastle upon Tyne
CALL NOW on 0161 839 5353 or email Jacob Golding - email@example.com