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| Job Location | Chepstow |
| Education | Not Mentioned |
| Salary | 40,000 - 60,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
Regulatory Affairs Specialist / EngineerThis highly innovative medical device manufacturer is actively looking for a Regulatory Affairs Engineer/Specialist to join their team. They are genuinely revolutionising certain applications withing their field and the successful candidate will be workingon high tech, innovative products which will have a huge impact on peoples lives.As a Regulatory Affairs Engineer/Specialist, you will be working with multiple product development teams supporting regulatory approvals as well as maintaining clinical literature and clinical evaluation reports. You will also be responsible for planning, managingand support of clinical trials.On offer is a highly competitive salary and benefits package as well as the opportunity to work on genuinely innovative products within a rapidly growing company.Responsibilities:To collaborate, author and/or review clinical evaluation reports for new product developmentUndertake and/or oversee literature searchesIdentify complications and side-effects for the intended use of devicesSupport, review and revision of clinical evaluations per MDD/MDRWork with Development teams in the preparation of regulatory documentsSupport CE marking and FDA submission processesPerforming tasks relating to regulatory affairsManage and conduct a programme of studies and related clinical activitiesSupport project teams and provide regulatory and commercial supportDrafting and approval of study protocolsPrimary contact and coordination of development teams, study sponsors, clinical test facilities, clinicians and CROs.Identify complications and side-effects, including incident rates, for the intended use of devicesSupport to the establishment, review and revision of the clinical evaluation per MDD/MDR.Provide support during ISO 13485 and other QMS/regulatory compliance audits and inspectionsQualifications/Experience:Experience within the medical device industryExtensive regulatory affairs experienceExperience with MMD, MDR, FDA 510K, CE marking, ISO 14917, ISO 13485 etc.Ideally degree educated within a science or engineering discipline