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| Job Location | Glasgow |
| Education | Not Mentioned |
| Salary | 40,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
REMOTE, OFFERING FLEXIBLE WORKING HOURS. However this role is covering the Scotland areaSalary - £40,000 (Negotiable based on experience)A fantastic opportunity for an experienced Quality Assurance and Regulatory Affairs Professional to join a dynamic Medical Device Company ready for commercialisation. We are breakthrough innovations in the pioneering field of regenerative medicine. Primary Role Quality Assurance: - Development and maintenance of an effective Quality Management - System and act as the Management Representative for the Quality - Management System. To develop and maintain a state-of-the-art Quality Management System in compliance with the changing international standards and regulations (including BS EN ISO 13485, 21 CFR Part 820, and all other applicable quality standards applicableto our products. Regulatory Affairs: - Act as the Person Responsible for Regulatory Compliance (PRRC) for the company.- Ensure all activities directly relating to the safety or performance of medical product are conducted in compliance with the changing international regulations (including MDR, the applicable US Code of Federal Regulations and other international territoriesas required).- Compile and maintain product registration documentation for sale of medical product in Europe, US, and other international jurisdictions. Experience - Experience of working within an ISO 13485 quality system is essential - Knowledge and experience of compliance with the Medical Devices Regulations and US FDA is essential- Ability to work in a multi-disciplinary team and build relationships- Experience hosting Notified Body audits is essential- Knowledge and experience of medical device registration in the EU and USA- Knowledge of Cosmetics Regulations is desirable- Demonstrates "can do" attitude and ability to use initiative