BTNX Inc.
Quality Assurance Associate at BTNX
Job Description
Launch your career in biotech with BTNX Inc. as an Entry Level Quality Assurance and Regulatory Affairs Associate based in Pickering, Ontario. Take the first step into a vital role that supports regulatory compliance and quality system functioning.
In this entry-level position, you'll help maintain BTNX’s Quality System to ensure effective operations and compliance with regulations like ISO13485:2016 and FDA QSR. You'll work closely with senior management, preparing necessary documents for product registrations and participating in audits. This role is perfect for recent graduates passionate about quality assurance in the healthcare sector.
Key Responsibilities:
• Monitor and update medical device regulatory requirements
• Maintain facility and product registrations with Health Canada and FDA
• Prepare documentation for product registration submissions
• Participate in internal audits and coordinate external audits
• Control documents through creation and revision ...
In this entry-level position, you'll help maintain BTNX’s Quality System to ensure effective operations and compliance with regulations like ISO13485:2016 and FDA QSR. You'll work closely with senior management, preparing necessary documents for product registrations and participating in audits. This role is perfect for recent graduates passionate about quality assurance in the healthcare sector.
Key Responsibilities:
• Monitor and update medical device regulatory requirements
• Maintain facility and product registrations with Health Canada and FDA
• Prepare documentation for product registration submissions
• Participate in internal audits and coordinate external audits
• Control documents through creation and revision ...