Our client is a fast growing digital health company developing an app-based platform that uses artificial intelligence (AI) to predict an individual’s risk of developing complications from their diabetes. Products and capabilities are far reaching even looking at cardio vascular and kidney disease etc.
They require a Head of Regulatory to ensure that products and the development cycle meets the requirements of standards. In particular it is anticipated they will be registered as a Class IIa Medical Device.
Transition of the remote management diabetes platform from non-regulated product to Class IIa in accordance with EU Medical Device Regulation.
Product registration and submission to regulatory authorities for medical devices including CE marking to EU Medical Device Regulation, US FDA and Canadian Medical Device Licence (MDL) etc.
Support risk management activities in accordance with ISO 14971 and EN 62304.
Ideally compliance expertise with ISO 13485, ISO 62304 and ISO 82304. Regulatory support for design and development and ISO27001 would also be a plus.
Under MDR fulfil the role of Person Responsible for Regulatory Compliance:
ensure conformity of the product is checked, in accordance with the quality management system under which the device is manufactured, before it is released technical 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 MDR reporting obligations referred to in Articles 87 to 91 of MDR are fulfilled in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV in MDR is issued EN ISO 13485 compliance:2016 to obtain CE marking and management of the process to obtain this and to act as Management Representative 21 CFR Part 820 Quality System Regulation for US market entry MDSAP certification Determination of global regulatory roadmaps and compliance strategy guidelines for new products (including China, Emerging markets and requirements for ORCHA top accreditation) Running and successful completion of audits; CQC, ISO 11073 & ISO 27001 Skills:
Previous experience of reporting to Senior Stakeholders Regulatory and quality experience working in regulatory affairs in the medical device, digital health or pharmaceutical industry To find out more about Real please visit
Real 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