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Research Engineer Risk Management Medical Devices

3.00 to 5.00 Years   Delhi   10 Jun, 2021
Bee5 Manpower Consulting
Job LocationDelhi
EducationNot Mentioned
SalaryRs 4.0 - 7 Lakh/Yr
IndustryIT - Software
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Designation: Research Engineer Risk Management Medical DevicesIndustry: Medical Devices Place of Posting: Kundli, Sonepat 2 KM from NCR Delhi Border (Singhu Border)Job Responsibilities & Duties

  • Preparation of safety and risk management documentation for Orthopaedic Implants and Medical Devices in compliance with MDR 2017 & ISO 14971.
  • Document and maintain repository of risk management plan (RMP), risk management, reports (RMR), Risk Assessment Summary (RAS), etc for various Orthopaedic implants and related medical device accessories as per SOPs.
  • In depth analysis of PMS data for preparation of risk files and template upgradation for existing technical files and risk files.
  • Prepare applicable standards for Orthopaedic Implants & medical devices as the EU Standards.
  • Provide support from risk management perspective for building various product design documents starting from design phase.
  • Other responsibilities as assigned by reporting manager.
Key Skills:Medical Device, Orthopaedic Implant Research, Risk, MDR, ISO 14971, documentation, (RMP, RMR, RAS, PMS Data, Risk Files, EU Standards, ISO 14971, MDD, MDR, Regulatory Affairs, Interpret Product Drawings.Required Candidate profileDesired Education, Experience, Skills & Competencies:
  • BE/ B.Tech/ M.Tech in Mechanical/ Bio-Medical/ Industrial Design with 4 plus year experience in preparation and updating Risk Management as per ISO 14971 in Medical Device manufacturing company.
  • Sound knowledge in Medical Device Directives (MDD) and its migration to Medical Device Regulations MDR
  • Sound knowledge of Regulatory Affair documentation for Medical Devices and ability to study and interpret product drawings.
  • Other responsibilities as assigned by reporting manager.
Key Skills:Medical Device, Orthopaedic Implant Research, Risk, MDR, ISO 14971, documentation, (RMP, RMR, RAS, PMS Data, Risk Files, EU Standards, ISO 14971, MDD, MDR, Regulatory Affairs, Interpret Product Drawings. ,

Keyskills :
researchtroubleshootingmarketingproduct developmentsafetycontinuous improvement facilitationiso 14971product designrisk managementmedical devicesrisk assessmenttechnical filesindustrial designregulatory affairsisopmsrasmdrrisk

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