Entry Level Regulatory Affairs Associate

Begin your journey in biotechnology as an Entry Level Quality Assurance and Regulatory Affairs Associate with BTNX Inc. in Pickering, Ontario. This role is an excellent opportunity for recent graduates to dive into compliance and system management.

The Quality Assurance and Regulatory Affairs Associate plays a pivotal role in supervising BTNX’s Quality System and ensuring adherence to essential regulations, including ISO
13485:2016 and IVDR. In this position, you'll collaborate with senior staff and aid in preparing regulatory submissions for products, which plays a critical part in the company's operations.

Key Responsibilities:

• Upkeep and monitoring of the Quality System

• Assist with product registration for FDA and Health Canada

• Involvement in internal and external audits

• Maintain control over essential documents for quality assurance

• Manage product labeling reviews and complaints

Requirements:

• Bachelor’s or master’s degree in a relevant field

• 0-2 years of experience or relevant skills

• Strong organizational ability and multitasking

• Excellent communication skills in written and spoken form

• Knowledge of ISO and regulatory systems preferred

Make a meaningful impact in healthcare through quality assurance at BTNX, advancing innovations in diagnostics.
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