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Prentice Associates Limited
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Irvine, Ayrshire and Arran
Regulatory Affairs Associate
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Salary: Up to £33,000 per annum |
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Overview
MAIN PURPOSE OF JOB AND OBJECTIVES Perform Regulatory tasks as instructed. Work towards meeting quality objectives as stated in quality system as applicable. KEY DUTIES Assist in the production and review of design dossiers, technical files and device master files, Product Approval Certificates. Preparation of regulatory submission for product approvals. Preparation of Custom Made device, Special Products paperwork and change assessments. Participate in Design Control, Risk Management, Post Market Surveillance and document changes Facilitate compliance with Vigilance System. Update and review all IFU, Packaging and Labelling. Other duties as required by RA department. QUALIFICATIONS & EXPERIENCE BSc Hons Degree PROFILE Regulatory Affairs experience in at least one of the following areas: Medical Devices, Food Supplements, Cosmetics or Foods. Excellent attention to detail High level of computer skills including familiarity with Microsoft packages such as Excel, Adobe etc Ability to work unsupervised Experience working in Quality Assurance or as a technical Officer would be considered. Strong team player Able to communicate with personnel in QA/R&D and other departments At Prentice Associates we aim to respond to your enquiry within 24 hours. If, however you have not heard within 7 days, on this occasion you have been unsuccessful. This job was originally posted as www.totaljobs.com/job/89610922