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Regulatory Affairs Manager

Real Staffing
Job LocationSwansea
EducationNot Mentioned
Salary50,000 - 65,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Our client is part of a group of global medical device companies. The brand specialise in sterile single-use surgical instruments, priding themselves on developing new and innovative products that are used for a variety of therapy areas. Reporting to theHead of Regulatory Affairs and based in Swansea there is some flexible working on offer if required for the chosen candidate.Role:

  • The Regulatory Affairs Manager will be responsible for management of a team of technical file writers who share responsibility for all technical files for the site.
  • Co-ordinate work undertaken by other specialists, clinical writer (s) and biocompatibility consultant etc.
  • Act as the on-site expert on all regulatory matters, providing advice, guidance to QA, Manufacturing and other managers
  • Create and maintain technical files to MDD requirements
  • The Regulatory Affairs Manager will update Technical files to MDR
  • Create and maintain technical documentation to US FDA requirements when needed
  • Update Technical files to meet new products/modifications updates to technical documentation and supplier changes
  • Oversee overseas registrations of products
  • Review of and approve documentation and document change orders
  • Assist in preparing responses to regulatory authorities
  • Write supplier agreements
  • The Regulatory Affairs Manager will also be responsible for the RA plans for the design and development teams to support Global markets
  • Assist and ensure devices are registered in EU/FDA and UK MHRA databases
  • Stay abreast of regulatory procedures and changes in regulatory climate
  • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance and addressing any issues arising.
Qualifications & Skills:
  • Ideally degree level education or practical experience in Regulatory Affairs
  • Medical devices to MDD/MDR standard
  • EU Medical Device regulations, harmonised standards and associated non-harmonised standards, Working Knowledge of US FDA requirements
  • Knowledge of MDSAP desirable but not essential
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 ManagementMDRTechnical FilesISO 13485MDDUS FDA

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