Description
Supporting the RA/QA Manager and the function in compilation of technical files, regulatory submission, design history files and compliance activities for the product lifecycle.The role of Quality Assurance Engineer & Regulatory Affairs Associate requires a solid understanding of electronic/software medical devices and will suit candidates from an engineering & quality background, you will require regulatory experience.
Candidates will require:
*Degree level education - BSc in Engineer or related field
*Medical Devices industry experience - essential
*Medical Devices Directive 93/42/EEC & 21 CFR Part 820 & ISO13485 experience
*Technical File and Registration experience
*Class II/III medical device experience
*Experience of electronic and/or software medical devices )
*Excellent communication and presentation skills
Further key responsibilities include:
*Risk Evaluation
*Support Internal Audits
*Support external Audits
*Support internal investigations and CAPA`s
*Assist in change management processes
*Review of technical standards and regulatory requirements for all products
Summary:
This is an excellent time to be joining a mid size medical device company in a growing and supportive team.
Please send through an up to date CV to Marco Heumann -