Regulatory Affairs Specialist - Abbott Medical Devices (Mississauga)

Abbott seeks a Regulatory Affairs Specialist for its Mississauga medical devices office to manage regulatory submissions and compliance with Canadian requirements. The role involves preparing license applications, interfacing with Health Canada, and coordinating across cross-functional teams in a hybrid work environment.

Responsibilities

• Prepare and submit robust regulatory applications to Health Canada
• Review, create, and approve engineering changes for medical devices
• Maintain current Canadian medical device regulations in submission databases
• Support product release process by reviewing and approving release requests
• Lead or participate in cross-functional project teams as needed

Requirements

• Undergraduate degree in Life Sciences, Engineering, or related field
• 3-5 years of experience with Canadian medical device regulatory submissions
• Experience preparing Class II-IV license applications and Investigational Testing Applications
• Knowledge of Canadian Food & Drugs Act and medical device regulations
• Strong written and verbal communication skills across organizational levels
• Ability to multitask, prioritize, and work in matrixed business environments

Compensation: $75,750-$111,100 CAD base