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| Job Location | Cardiff |
| Education | Not Mentioned |
| Salary | £38,000 - £48,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent, full-time |
Senior Compliance Specialist | Medical Devices | South Wales | PermanentYour CompanyA leading manufacturer and supplier of Medical Devices is looking for a Senior Compliance Specialist 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 organisations and have an international presence in over 100 different countries. Your New RoleYou will be joining the team as a Senior Compliance Specialist and will be reporting into the Regulatory Compliance Manager. This is an important role in the business as this role is the key to success for the company in such a regulated environment. You will be leading compliance initiatives within the business and ensuring the group operating procedures are implemented on a day-to-day basis. You will be responsible for leading internal audits and supporting team with external auditing. You will be supporting the Design Control process in accordance with 21 CFR Part 820.30 and SOPs and supporting with the implementation and maintenance of design history files (DHFs). As a Snr Compliance Specialist you will be working closely to provide the business with compliance support and will be responsible for recommending improvements to processes and supporting the implementation of these recommendations with senior management. To be successful for this roleYou will have previous experience leading internal audits and supporting external audits. You will have a minimum of 3 years experience within Medical Devices in Quality, Regulatory, or Technical role, with a degree in Science or Engineering. You will have strong communication skills as you will need to liaison with the regulatory manager, the technical team, other locations and other departments daily. You will have experience with SOPS, process improvement, and knowledge of regulatory requirements for medical devices including; Medical Device Directive (MDD), and ISO 14971 & 13485. You will also have previous experience with Medical Device Regulation (MDR 2017/745). It is beneficial if you have previous experience with electronic data management systems for medical devices. 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 organisation. What to do nowIf this sounds like you please click "apply now". I will be in contact with successful candidates within 2-3 days.