Naukrijobs UK
Register
London Jobs
Manchester Jobs
Liverpool Jobs
Nottingham Jobs
Birmingham Jobs
Cambridge Jobs
Glasgow Jobs
Bristol Jobs
Wales Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Head of Regulatory Affairs

Real Staffing
Job LocationMacclesfield
EducationNot Mentioned
Salary56,000 - 70,000 per annum, inc benefits
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Our client is a fast growing digital health company developing an app-based platform that uses artificial intelligence (AI) to predict an individuals risk of developing complications from their diabetes. Products and capabilities are far reaching even lookingat 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.RoleTransition 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 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 :
BiotechnologyPharmaceuticalRegulatory AffairsQualityMedical DeviceDigital Health

APPLY NOW

Head of Regulatory Affairs Related Jobs

© 2019 Naukrijobs All Rights Reserved