Our client is a global MedTech company that is a manufacturing leader in infection control, decontamination and sterilization. With plans for further growth in a highly-regulated environment. This role will help to ensure the organisation maintains its impeccable standard of quality and regulatory assurance. To achieve this, we have been tasked with identifying and recruiting a Quality and Regulatory Assistant to join their UK team.

The ideal candidate will have experience working with Quality Management Systems and will assist the Quality and Regulatory Manager in the implementation of regulatory aspects of the Global QMS to enable a successful MDR/ISO13485 transition to TUV SUD.

Key responsibilities will include:

• Identify areas for improvement. Design, build and implement new quality processes into the organisation.
• Drive continuous improvement in all aspects of the existing quality operation
• Risk Management according to ISO14971
• Post Market Vigilance according to MDR requirements
• Assist in the implementation of clinical evaluation and technical file SOPs and review of documents associated with this.
• Maintenance of Technical Documentation
• Maintenance of medical device registrations with MHRA and EUDAMED

To be considered for the role, you must closely match the following criteria:

• QMS experience required.
• ISO14971/Risk Management experience required.
• PMS experience required.
• Knowledge / experience of ISO 13485 is desirable.
• IT skills.
• Able to interact with all levels of the business.
• Organised and able to prioritise work.