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

Regulatory Affairs Manager remote or flexible working

Real Staffing
Job LocationLeeds
EducationNot Mentioned
Salary£45,000 - £55,000 per annum, negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Our client is a medical device company with a family feel up-scaling and looking for a Regulatory Manager to join the team.The Regulatory Affairs Manager will be responsible for ensuring that the company is adhering to all applicable regulations such as but not limited to Regulation (EU) 2017/745 (MDR), and the new UKCA Certification regulations, in a manner that is proportionate to the risk class (Class III medical devices). The Regulatory Affairs Manager will need to develop strategies to ensure regulation compliance and to make sure that all necessary documentation is completed and submitted.The Regulatory Affairs Manager will also be responsible for working with international distribution partners to ensure that products meet all the local regulations within each market.RESPONSIBILITIES:

  • Be the subject matter expert on Regulation (EU) 2017/745 (MDR) and UKCA regulations
  • Lead the Regulation (EU) 2017/745 (MDR) transition - working with colleagues to establish, document, and implement a quality management system that ensures compliance with the Regulation (EU) 2017/745 (MDR) and UKCA regulations - Class III products (ideally).
  • Follow MDR/ISO and UKCA developments closely and develop, maintain, keep up to date and continually improve the quality management system.
  • Draw up and keep up to date the technical documentation and the EU declaration of conformity in accordance with the Regulation (EU) 2017/745 (MDR) requirements.
  • Implement, maintain, keep up to date and continually improve a post-market surveillance system in accordance with Regulation (EU) 2017/745 (MDR) requirements.
  • Establish, implement, and maintain a system for recording and reporting of incidents and field safety corrective actions accordance with to Regulation (EU) 2017/745 (MDR) requirements.
  • In the case of investigational devices - ensure that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation (performance study) and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient.
  • The Regulatory Affairs Manager will conduct internal and support external MDR and UKCA audits
  • Manage Notified Bodies or any other regulative inspections related to MDR and UKCA
  • When required liaise with regulatory bodies - MHRA, EU Authorised Representative, etc
  • Perform internal MDR and UKCA training were required.
    • Relationships:
  • Internal: Board of Directors, all departments
  • External: UK and International Notified Bodies, UK and International Regulatory Agencies, EU Representative (ER), Distribution partners, RA/QA Consultants.
    • Experience:
  • experience within Medical Devices
  • Experience within understanding of Regulation (EU) 2017/745 (MDR) - Class III products or similar medical devices
  • Experience in compiling and maintaining a clinical evaluation report (CER).
  • Experience in establishing and maintaining post-market surveillance plans (PMS Plan), conducting post-market surveillance (PMS), and compiling post-market surveillance reports (PMSR)
    • 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 Required skills
  • Medical Devices
  • Regulatory Affairs
  • Risk Management
  • MDR
  • ISO 13485
  • DHF
  • market approval

    • Keyskills :
    Medical Devices Regulaty Affairs Risk Management MDR ISO 13485 DHF market approval

    APPLY NOW

    Regulatory Affairs Manager remote or flexible working Related Jobs

    © 2019 Naukrijobs All Rights Reserved