QA and Regulatory Affairs Associate Position

Embark on a fulfilling career at BTNX Inc. as a Quality Assurance and Regulatory Affairs Associate in Pickering, Ontario. This position offers hands-on experience in compliance, quality management, and regulatory submissions.
In this entry-level role, you will uphold BTNX's Quality System and ensure alignment with complex regulations such as ISO13485:2016 and Health Canada guidelines. Candidates should have a degree in a relevant field and a keen interest in regulatory affairs to thrive in the biotech diagnostics industry.
Key Responsibilities:
• Ensure regulatory requirements are communicated to management
• Maintain current product registrations with Health Canada, FDA, and CE
• Assist in the drafting of documents for regulatory authorities
• Participate in internal audits and maintain document control
• Address complaint files and risk management processes
Requirements:
• Bachelor’s or master’s degree in life sciences or related field
• Up to 2 years of...