Quality & Regulatory Officer - Fixed Term Contract

Role Title

Quality & Regulatory Officer

Fixed Term Contact

Bedford

£35,000 Benefits

Role Profile

Support the QA and Business Development teams with the essential regulatory and licensing information for Customer requirements

• To provide customer support with maintenance of existing licences
• To support and advise customers with new licensing and regulatory affairs
• To prepare and coordinate critical regulatory submissions
• To liaise between customers and regulatory authorities
• To write support arguments, risk assessments and reports
• Assist in the compilation and review of standard operating procedures, work instructions and other relevant documentation
• To support Quality Assurance team with internal audit activities
• Day to day running of the quality management systems and processes including, but not limited to, internal compliance audits in line with ISO 9001, ISO 13485, FEMAS, Soil Assication, HPRA, MHRA and FDA, product inspections, document control and identification, CAPAs and control of non-conforming products.
• To undertake any other such duties that from time to time may be required to maintain quality levels within the business

Skills & Experience

• Ability to function in a dynamic, contracting environment
• Excellent presentation and communication skills
• Ambitious, with the potential to contribute to a rapidly growing business.
• High level of accuracy
• Strong IT skills

Client information

Exceptional high growth international manufacturing operation based in Bedfordshire.

Remuneration

£35,000 Benefits

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