Senior Quality and Regulatory Associate

6 months ago


Derby, United Kingdom Guided Solutions Full time

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.

**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.


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