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Regulatory Compliance and Quality Assurance Specialist

3 months ago

Pickering, Ontario, Canada BTNX Inc. Full time

Company Overview

BTNX Inc. is a prominent biotechnology firm focused on swift, point-of-care diagnostic solutions. As a leader in the industry, we are committed to pioneering research and the creation of sophisticated in-vitro diagnostic (IVD) tests. Our services span across laboratories, clinics, hospitals, and physician offices, with a strong operational presence in Canada and the USA, as well as a broad international footprint. Located in Pickering, ON, BTNX provides an exciting opportunity for a driven individual to become part of our team.

Role Overview

The Regulatory Compliance and Quality Assurance Specialist plays a crucial role in maintaining and overseeing the Quality Management System to ensure its effective implementation and operation. This position necessitates a comprehensive understanding of all aspects of the organization and the various regulations and quality frameworks applicable to BTNX Inc. The Specialist is accountable for executing all tasks mandated by relevant regulations, including ISO13485:2016, US FDA QSR, IVDR, and Health Canada MDR.

Key Responsibilities

  • Keeping Senior Management informed about medical device regulatory standards and ensuring necessary modifications or updates are enacted
  • Maintaining current facility and product registrations, including Health Canada, FDA, and CE mark
  • Assisting in the preparation of documentation and submissions for FDA, Health Canada, EU, and other international product registrations
  • Participating in the updating and maintenance of BTNX's ISO 13485 Quality Management System
  • Engaging in the internal audit process and coordinating external audits
  • Document Control: Creating, revising, reviewing, approving, and managing documents
  • Reviewing complaint files, Nonconformity Documentation forms, and corrective/preventative actions
  • Conducting risk management to meet all applicable regulatory standards
  • Reviewing and approving content for Product Labeling
  • Managing recalls and medical device reporting
  • Assisting in organizing Management Review meetings

Required Skills & Qualifications

  • Bachelor's or Master's degree or equivalent in Regulatory Affairs, Medical Science, Life Science, or a related field
  • At least 2 years of relevant experience or demonstrated capabilities
  • Strong organizational and multitasking abilities
  • Knowledge of Regulatory Affairs (strongly preferred)
  • Familiarity with Quality Systems (preferred)
  • Experience with FDA or Health Canada, and/or European in-vitro diagnostic medical device regulations
  • Excellent communication skills, encompassing written, verbal, and telephone interactions

Compensation will be based on experience.