Regulatory Affairs & QA Specialist

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Location
Montreal
Job Type
Permanent position
Category
Medical
Job number
091594
Scolarship
BAC
Spoken and written languages
Français, English
Used softwares
Suite Office

Description

  • Evaluate all complaints classified as Potentially Reportable Events (PRE) and determine if Vigilance Reporting requirements apply within regulatory timelines. Complete applicable vigilance records and obtain approval.
  • Prepare applicable Health Canada reports, obtain approval and submit reports to Health Canada as per applicable regulatory timelines.
  • Prepare follow-up and final Health Canada reports, obtain approval and submit reports to Health Canada.
  • Manage reporting of reportable events that occurred outside Canada as per applicable requirements of the Canadian Medical Devices Regulations.
  • Ensure completion of adequate tools (Trackwise Digital, LLC…) to document each step of the process.
  • Monitor and maintain familiarity with applicable regulations and assist with the review and revision of related local procedures.
  • Assist in the execution and improvement of regulatory processes and interactions with regulatory agencies.
  • Participate and support audits and inspections
  • Work closely with local Customer Service to ensure a compliant process. Ensure regular meetings and related training.
  • Assist in the completion of related local and Corporate QMS indicators and the definition and execution of action plans.
  • Assist RQC US in the completion of Vigilance activities if needed.
  • Assist with the management of FCA and FSCA.
  • Assist with the Quality Management System as per activities assigned by the QA/RA Manager.

Informations complémentaires

  • Strong Knowledge of Canadian Medical Devices Regulations - MDR SOR ∕98 – 242
  • Knowledge of the FDA 806 & 803
  • Knowledge of QMS requirements

 

Specific knowledge

  • Bachelor degree in Science, biology.
  • 5 years of experience in the Medical Device Industry
  • Knowledge of InVitro Diagnostic industry is an asset
  • Strong computer skills Microsoft office (Word, Excel, Power point, outlook, Teams)
  • Rigor, reliability, respect of timelines
  • Strong analytical skills and ability to identify and propose solutions

Autres logiciels

Trackwise Digital

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