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Clinical Research Engineer - Medical Devices

2.00 to 4.00 Years   Delhi   18 Dec, 2020
Bee5 Manpower Consulting
Job LocationDelhi
EducationNot Mentioned
SalaryRs 3.0 - 5 Lakh/Yr
IndustryIT - Software
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

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

  • Support execution of global & local Regulatory Affairs clinical projects by adhering to SLAs within budget in a timely manner.
  • Prepare regulatory documents & ensure its complies with requirements.
  • Co-monitor the visits with other clinical research associates for the quality execution of clinical trials, quality audits and inspection issues.
  • In collaboration with the reporting manager coordinate country level protocols, feasibility study, coordinate site assessments and take initiatives for site local clinical trials.
  • Networking with institutions and academicians in identifying good centres for clinical trials.
  • Other responsibilities as assigned by reporting manager.
Key Skills:Clinical Trials, Orthopedic Implants, Medical Devices, Global & Local Regulatory Affairs Documentation, Audit & Inspections, Protocols, Feasibility Study.Required Candidate profileDesired Education, Experience, Skills & Competencies:
  • BE/ B.Tech/ MSC/ M.Tech in Mechanical/ Bio-Medical/ Industrial Design with 2 plus year experience in Regulatory Affairs related research in Medical Device/ Automobile manufacturing company.
  • Ability to perform quality clinical trials, track tasks performed by clinical research associate, CTAs & PMS for their timely and effective execution for local clinical trials Ability to study and interpret drawings.
  • Sound knowledge of Regulatory Affair documentation for Medical Devices and ability to study and interpret product drawings.
  • Ability to coordinate country level protocol feasibility, coordinate site assessments and take initiatives for local clinical trials.
  • Networking with institutions and academicians in identifying good centres for clinical trials.
  • Other responsibilities as assigned by reporting manager.
Key Skills:Clinical Trials, Orthopedic Implants, Medical Devices, Global & Local Regulatory Affairs Documentation, Audit & Inspections, Protocols, Feasibility Study.,

Keyskills :
researchtroubleshootingmarketingproduct developmentsafetyclinical research associatescontinuous improvement facilitationquality auditmedical devicesclinical trialsclinical researchindustrial designregulatory affairspmsslasctassounddesign

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