Cloud DX, Inc.

Cloud DX, Inc.

Quality and Regulatory Specialist

Kitchener, ON, Canada

Sponsorship not specifiedDetected 126 days ago
Machine LearningDeep LearningExcelClinical TrialsFDA RegulatoryMedical DevicesResearchCommunicationOrganizational Skills

About the role

  • Use cases include acute and chronic remote automated monitoring (RAM), hospital at home deployments and distributed clinical trials.
  • This role is ideal for a Quality Management professional who takes initiative, operates independently, and thrives in structured, standards-based environments.

Responsibilities

  • Support communications with relevant regulatory bodies in North America and the EU to support clinical trials and device licensing/clearance.
  • Maintain internal quality processes, including shipping/receiving, incoming inspections, device assembly, and product releases.
  • Interface with the R&D team to ensure that PDLC processes and design principles fulfill anticipated regulatory requirements
  • Perform gap analysis between existing processes and documentation and manage the updating process
  • Support internal and external audits.
  • Demonstrated ability to work independently and drive tasks through to completion

Requirements

  • Bachelor's degree in engineering with P.Eng. designation
  • Practical experience maintaining or supporting a Quality Management System
  • Working knowledge of ISO 13485 and or ISO 9001 requirements
  • Strong attention to detail with the ability to identify inconsistencies or gaps in documentation
  • The key Vitaliti differentiator is the ability to gather very accurate telemetry from easy to use, continuous and spot monitor devices that can immediately be analyzed by modern artificial intelligence systems.

Benefits

  • Be responsible for ensuring that QMS processes and documentation conform to applicable standards required for regulatory approval (Health Canada, FDA, CE)
  • Interface with Ethical Research Boards and participating academic or health institutions during studies and trials
  • 5+ years of experience working within a regulated quality environment, preferably in medical device development and commercialization
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