Quality Assurance Associate at BTNX

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 ISO
13485:2016 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 processes

Requirements:

• Bachelor’s or master’s degree in Regulatory Affairs or related field

• 0-2 years of relevant experience or demonstrated abilities

• Strong organizational and multi-tasking skills

• Excellent written and verbal communication skills

• Knowledge in regulatory affairs is preferred

Start your path in regulatory affairs and quality systems, contributing to healthcare innovations at BTNX in Pickering.
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