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Regulatory Affairs Associate Medical Devices

Andersen Caledonia
Job LocationStrathclyde Business Park
EducationNot Mentioned
Salary£23,000 - £26,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Andersen Caledonia is a global leader in sterilisation and testing of products for the medical device, pharmaceutical and healthcare industry. As a results of business growth and changes in the medical device regulations, we are recruiting a Regulatory Affairs Associate to build on the team responsible for regulatory compliance for the medical devices we manufacture.The Regulatory Affairs Associate will be based within the companys technical team and will report to the Technical & Regulatory Affairs Manager.About the jobAs the Regulatory Affairs Associate, your job function will be;

  • Assist technical and regulatory departments in writing, collating and maintenance of the Technical Files and ensuring regulatory compliance.
  • Assistance in quality and regulatory projects, processes and activities including transitions to MDR & UKCA mark
  • Review of changes in the Medical Device industry and document Gap Analysis
  • Audit critical suppliers of Medical Device raw materials (associated with CE Marked Product)
  • Obtain Post Marketing Surveillance data from customers - setting & maintaining plans and documenting results
  • Assisting in documenting MDD/MDR related complaints, Vigilance/Incident reporting/recall process
  • Assist in documenting/reviewing supplier agreements/contracts
  • Assisting with regulatory submissions
  • Collaborate with internal departments for resolving any regulatory discrepancies
    • Essential skills and experience requiredTo be considered for this position, the successful candidate should;
  • Minimum two years background in Medical Device Industry
  • Working knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971, FDA 21 CFR part 820, MDD 93/42/EEC
  • Knowledge of Regulation 2017/745
  • Development and writing of CE marking technical files
  • Proactive and excellent organisational skills
  • Competent in Microsoft Office
  • Meticulous attention to detail
    • Desirable skills and experience requiredIdeally the candidate would also possess some of the following skills;
  • experience performing or participating in internal/supplier/customer audits
  • experience with risk assessments
  • experience of setting up post marketing plans and analysis of obtained information
  • experience of biocompatibility testing/reviews
    • Required skills
  • Medical Devices
  • Regulatory Affairs
  • Technical Files
  • ISO 13485

    • Keyskills :
    Medical Devices Regulaty Affairs Technical Files ISO 13485

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