Job Title

Cure Talent are delighted to be partnered with a well-established, British Medical Device Manufacturer who, due to continued growth and investment, have an exciting opportunity for a Regulatory & Quality Assistant to join their team.This role is predominantly Regulatory Affairs focused, supporting the creation and maintenance of Technical Files and regulatory submissions in line with ISO 13485, MDR and UK MDR requirements. The position will also involve elements of Quality Assurance, including internal auditing and supporting the ongoing compliance of the Quality Management System.The ideal candidate will have a proven background within Medical Device Regulatory Affairs and possess a strong understanding of ISO 13485 and medical device regulations. You will have experience in the creation and/or updating of Technical Files under MDR, assisting with regulatory submissions and internal auditing.Key Responsibilities:Assist with the preparation of regulatory submissions and Technical Files to EU MDR 2017/745 and UK MDR 2002Conduct internal audits and follow up on corrective actionsMaintain documentation including procedures, protocols, validation reports, audit records, and CAPAsSupport the maintenance of the companys QMS in accordance with ISO 13485:2016Monitor changes in regulations and support implementation of updates to internal processesCollaborate with cross-functional teams including Engineering, Design, Sales, and Customer Service to ensure compliance is embedded throughout the organisationProvide support during notified body, supplier and customer auditsThe ideal candidate will have:Proven experience in a Regulatory Affairs focused role within medical devicesExperience in the compilation and updating of Technical Files under MDRProven knowledge and experience of ISO 13485, EU MDR, and UK MDRExperience with Class 2a devices as a minimumISO 13485 Internal or Lead auditor qualification is highly advantageous