Head of Regulatory Affairs

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I've been retained by a fast growing digital health company developing a diabetes app-based platform that uses artificial intelligence to predict an individual's risk of developing complications from their diabetes.The company are looking for a Head of Regulatory Affairs to ensure that products and the development cycle meets the requirements of standards. In particular it is anticipated Class IIa Medical Device.The company have offices in Cheshire and will consider remote working and candidates requireing flexible working. RoleTransition of the remote management diabetes platform from non-regulated device to Class IIa in accordance with EU Medical Device Regulation 2017/745.Product registration and submission to regulatory authorities for medical devices including CE marking to EU Medical Device Regulation 2017/745, FDA, 510(k) and Canadian Medical Device Licence (MDL).The Head of Regulatory Affairs will support risk management activities in accordance with EN ISO 14971 and EN 62304. Ensuring compliance with ISO 62304 and ISO 82304. Regulatory support for design and development lifecycle on the platform, Gestational Diabetes platform and risk prediction algorithms including:HIPPA, DSPT, DTAC, DCB0129, Cyber essentials, Web Content Accessibility Guidelines (WCAG) 2.1 level AA compliant, CQC, ISO27001 compliance, ISO 62304 and ISO 82304 complianceUnder MDR fulfil the role of Person Responsible for Regulatory Compliance which requires the following duties:ensuring conformity of the product is checked, in accordance with the quality management system under which the devices are manufactured, before a device is releasedtechnical documentation and the EU declaration of conformity are drawn up and kept up-to-date;post-market surveillance obligations are complied with in accordance with Article 10 (10) of MDRreporting obligations referred to in Articles 87 to 91 of MDR are fulfilledin the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV in MDR is issuedEN ISO 13485 compliance:2016 to obtain CE marking and management of the process to obtain this and to act as Management Representative21 CFR Part 820 Quality System Regulation for US market entryMDSAP certificationDetermination of global regulatory roadmaps and compliance strategy guidelines for new products (including China, Emerging markets and requirements for ORCHA top accreditationRunning and successful completion of audits; CQC, ISO 11073 & ISO 27001Skills:Previous experience of reporting to Board Level managementRegulatory and quality experience working in regulatory affairs in the medical device or digital health industryRegulatory affairs or in quality management systems relating to medical devices. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales