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Job Location | Cardiff |
Education | Not Mentioned |
Salary | £30,000 - £40,000 per annum |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent, full-time |
Compliance Associate (QA/RA) | Medical Devices | South Wales | PermanentYour CompanyA leading manufacturer and supplier of Medical Devices is looking for a Compliance Associate to join their team at their headquarters in South Wales, UK. They are a major supplier of medical devices to the NHS and other private organizations, and have an international presence in over 100 different countries. Your New RoleYou will be joining the team as a Compliance Associate and will be responsible for supporting regulatory compliance to relevant regulations, and supporting the organizations transition to MDR in line with industry requirements. As a compliance associate you will be responsible for; maintenance of technical files, supporting departments in regulatory external audits and internal audits, and performing risk assessments. To be SuccessfulYou will need to have previous experience within a regulatory affairs or quality assurance role within medical devices. You must have a knowledge of regulatory requirements for medical devices including ISO 13485, ISO 14971, and Medical Device Directive (MDD). In order to be successful you will have excellent communication skills and be bale to work effectively in project teams. It is beneficial but not mandatory that you understand design controls per 21 CFR Part 820.30, have experience with customer complaints, and have participated in an internal auditing program. You will a degree within a scientific related field, or have the relevant experience. What you will get in returnThis is a permanent position with a competitive salary on offer. They are extremely busy with the manufacturing of medical devices during COVID and so this is a great opportunity to gain more experience and grow within the organization. What to do nowIf this sounds like you please click "apply now". I will be in contact with successful candidates within 2-3 days.