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Regulatory Affairs Manager

Office Angels
Job LocationLondon
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

My client is looking for a Regulatory Affairs Manager

  • The ideal candidate will be educated to degree level (or equivalent), preferably in a Science or Engineering discipline, and will bring previous experience of working within Regulatory Affairs in the Medical Device or IVD field
  • alongside this, we are looking for candidates with a strong working knowledge of EU Medical Devices Directives, (90/385/EEC and/or 93/42/EEC and/or 98/79/EC), knowledge and understanding of the EU Medical Devices Regulations, (Regulation (EU) 2017/745 and 2017/746) and experience working within an ISO 13485 certified Quality System
  • Experience of working with regulatory frameworks outside the EU is desirable, but not essential.
  • Good understanding of global regulatory requirements
  • Good knowledge of Quality Management Systems
  • experience within the Medical Devices industry.
  • Previous experience within Quality Assurance and/or Regulatory Affairs would be a distinct advantage
  • Good working knowledge of Word and Excel
  • Good command of spoken and written English
  • Attention to detail
  • Variety of work experience a plus
  • Ensuring the declaration of conformity and technical documentation have been drawn up and, where applicable, that the manufacturer has carried out an appropriate conformity assessment procedure
  • Having an available copy of technical documentation, declaration of conformity, and, if applicable, relevant certificates, including any amendments and supplements for inspection by the MHRA
  • Providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
  • Forwarding requests made by the MHRA for samples to the manufacturer to ensure that the MHRA has samples or has been given access to the device
  • Cooperating with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices
  • Informing the manufacturer about complaints and reports from health care professionals, patients and users about suspected incidents relating to a device for which they have been designated
  • Terminating legal relationship with the manufacturer if they act contrary to its obligations under these Regulations and inform the MHRA and the relevant notified body of that termination
  • responsible for the design, maintenance and further development of the QM processes
  • ensuring adequate training of employees on the respective QM processes
    • Office Angels acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. Office Angels UK is an Equal Opportunities Employer.By applying for this role your details will be submitted to Office Angels. Our Candidate Privacy Information Statement explaining how we will use your information is available on our website. Required skills
  • Regulatory Affairs Manager

    • Keyskills :
    Regulaty Affairs Manager

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