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Head of Regulatory

Real Staffing
Job LocationMacclesfield
EducationNot Mentioned
Salary50,000 - 75,000 per annum, pro-rata, inc benefits
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Our client is a fast growing digital health company developing a app-based platform that uses artificial intelligence to predict an individuals risk of developing complications from their diabetes including cardio vascular and kidney disease etc.The company requires 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.RoleTransition of the remote management diabetes platform from non-regulated device 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).Support risk management activities in accordance with EN ISO 14971 and EN 62304.Ideally compliance expertise with ISO 62304 and ISO 82304. Regulatory support for design and development lifecycle and ISO27001 etc.Under MDR fulfil the role of Person Responsible for Regulatory Compliance:

  • ensuring conformity of the product is checked, in accordance with the quality management system under which the devices are manufactured, before a device 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 Board Level management
  • Regulatory and quality experience working in regulatory affairs in the medical device or digital health industry
  • Regulatory 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 andWales

Keyskills :
Medical DevicesRegulatory AffairsRisk ManagementMDRISO 27001ISO 13485IEC 62304MDD510KCE MarkDigital HealthMarket approval

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