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*** Principal Quality Assurance/Regulatory Affairs Officer - Preston - Pharmaceutical/Medical Devices - Salary £28,000 - £30,000 ***

The role

Reporting to the head of the department, the successful applicant will work as part of a team in the Quality and Regulatory division. The division is very active in new product development and therefore requires regulatory advice of high quality, particulary on medical devices.

A knowledge of risk assesments, classification of medical devices, determing the most appropriate regulatory path for various products to satisfy MDD requirements.

The creation and maintenance of techincal files as well as being actively involved in NPD, making sure correct regulatory paths are chose and documented. Quality aspects covering the testing and acceptance of materials for production/labatory will be required.

Continuos Improvement initiatives and introduction of new processes for overall improvemnt of the QMS will be required as will a knowledge of regulatory requirements outside the medical directive i.e biocide directive and cosmetic directive.

Experience of contact with MHRA and other notified bodies.

The Person

You will have knowledge of ISO13485 and ISO9001 and Medical Device Directive 93/42/EEC.

Experience with managing and improving Quality Management Systems, as well as experience with product development to resolve QA/RA issues.

Knowledge of Sterilization methods and familiarity with validation processes and supplier auditing.

Although a microbiological qualification is not essential a good amount of experience is required. A degree in Chemistry is desirable.

The Salary

£28,000 - £30,000