Quality Systems and Regulatory Affairs Specialist

Montreal, On-Site

Full-Time, Permanent

About Galenvs Sciences Inc.

Galenvs Sciences Inc. is a biotechnology Startup based in Montreal, Quebec. Galenvs offers turn-key platforms and solutions for researchers and clinicians in academic, government, biotech, and pharmaceutical labs. Galenvs specializes in magnetic-based nucleic acid isolation formulations informed by machine learning technology. Galenvs’ innovative solutions are used across North America, South America, and Asia.

Position Summary

The Quality System and Regulatory Affairs Specialist will be called upon to work in close collaboration with the various departments of the company to ensure the implementation and maintenance of the quality management system, as well as the filing and compliance with regulatory requirements for development, marketing and sales of medical devices.

Responsibilities

  • Lead in defining regulatory strategies and plans to optimize commercialization.
  • Lead in defining regulatory submission requirements by region.
  • Ensure that regulation-driven requirements are captured and addressed throughout product development.
  • Prepare and manage product submissions and renewals with regulatory bodies
  • Participate on project teams and provide regulatory input as part of product development planning, maintenance, launch activities, and long-range planning
  • Write, maintain, review and revise the quality and related procedures (SOP), R&D/production documentation, work instructions and forms
  • Perform internal training and follow-up with employees to ensure efficiency of the quality management system
  • Coordinate internal and external audits
  • Manage corrective and preventive actions, nonconformities, etc.
  • Manage evolution of the QMS towards an electronic version to accommodate support for additional medical devices into the QMS
  • Perform other duties as assigned

Qualifications:

  • University degree in Sciences, Engineering or other related field
  • Minimum of 3 years of experience in quality management system
  • Experience in regulatory submissions & approvals (Health-Canada, FDA, CE)
  • Excellent technical writing skills (in English)
  • Knowledge of ISO 13485 (Strong Asset), IEC-60601, ISO 14971, ISO 15189
  • Experience with Health Canada Medical Device regulations and/or US CFR 820.
  • Good understanding of quality management system for medical devices
  • Experience working with product development and new product introduction (NPI) processes.
  • Dynamic and ability to work in a team
Job Category: On-site
Job Type: Full Time
Job Location: Montreal (Quebec)

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