Quality Technician

Hales Group are happy to be working alongside their client, to assist them in finding a Regulations & Quality Technician to join their busy R&D Department. The role is based in a rural location, so transport is essential.


The purpose of this role is to assist with supporting the department through the following activities below, maintaining continuous improvement by implementing your previous experience and knowledge from a quality background, whilst delivering and producing regulations and compliance.

Hours and Salary:

This is a full-time position - 40 hours per week Monday-Friday, 8.30am - 5pm - Salary from £36,000 p/a- willing to negotiate for the right experience.

Duties Include:

• Supporting and guiding the design team in the compilation or remediation of supporting documentation to ensure regulatory compliance.
• To lead and author key documents within the technical file.
• Guiding the marketing team in producing regulatory strategy and then executing for global product registrations.
• To author procedures and templates to support the regulatory function.
• Supporting the QA function where appropriate, including CAPA and internal audits.
• Ensuring compliance with EU MDR and UK MDR.
• Supporting with the development of the ISO 13485 QMS.
• Assisting with the strategy development regulations, including all test plans.
• Compiling technical files and remediation.
• Labelling and packaging compliance documents.

Essential Requirements

• Must have a good understanding of EU/UK Medical Device Regulations (MDR).
• Ability to author and/or lead development of key documents within a technical file, e.g. Clinical Evaluation Report (CER), Risk Management File (RMF), Post Market Clinical Follow Up (PMCF).
• Knowledge of Instructions for Use (IFU), labelling and packaging requirements.
• Experience of leading or contributing to global product registrations.
• Good knowledge of ISO 13485, ISO 14971.
• Excellent communication skills; both internally and externally.

Desirable

• Familiarity of NHS supply chain quotation/registration process.
• Knowledge of the following IEC standards (60601-1, 60601-1-2, 60601-2-52, 62304, 62366-1)
• Experience with MEDDEV 2.7.1 Clinical evaluation.

Company Benefits

• 25 days annual holiday plus bank holidays
• Free parking
• Free tea and coffee
• Company events
• Company pension

For more information on this role, please apply by uploading a CV and one of our team will be in touch!