Quality Assurance Associate at BTNX Inc.

Join BTNX Inc. as a Quality Assurance and Regulatory Affairs Associate based in Pickering, Ontario. This entry-level position emphasizes regulatory compliance and quality system management across industries.

As a critical member of the Quality Assurance team, you'll ensure adherence to ISO
13485:2016, FDA QSR, and other regulatory standards. You will assist in the maintenance of documents and oversee product labels, while supporting audits and regulatory submissions. This role suits recent graduates eager to delve into the biotechnology sector.

Key Responsibilities:

• Inform management about medical device regulatory updates

• Ensure accuracy of facility and product registrations

• Assist with documentation for FDA and international registrations

• Involve in the maintenance of ISO 13485 QMS

• Manage document control and review complaints

Requirements:

• Relevant degree in Medical or Life Science

• 0-2 years of experience preferred

• Strong organizational skills

• Familiarity with Regulatory Affairs

• Excellent written and verbal communication

Immerse yourself in quality assurance processes at BTNX Inc. while developing invaluable regulatory expertise.
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