We are looking for a Quality and Regulatory Officer to support our QA and Business Development teams with the essential regulatory and licensing information for our 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, goods in, inspection activities, internal compliance audits in line with ISO 9001, ISO 13485, MHRA and FDA, product inspections, document control and identification, CAPAs and control of non-conforming products.
To represent the company at key customer meetings and audit visits.
To promote the Regulatory Services function externally.
To undertake any other such duties that from time to time may be required to maintain quality levels within the business
Skills & Competencies:
Ability to function in a dynamic, contracting environment
Excellent presentation and communication skills
Ambitious, with the potential to contribute to a rapidly growing business.