Regulatory Affairs Specialist

📋 Description

• Manage regulatory submissions, registrations, renewals for Health Canada
• Ensure compliance with Food and Drugs Act, Medical Devices Regulations
• Monitor regulatory changes and advise internal teams
• Support labeling, advertising, and promotional material review
• Liaise with Health Canada and other agencies on registrations and inquiries
• Maintain regulatory documents and technical files

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering, or related
• 3+ years in regulatory affairs in pharma, medical device, or regulated industry
• Strong knowledge of Canadian regulatory requirements and Health Canada submissions
• GMP, GCP, and ISO familiarity is a plus
• Regulatory writing, documentation, communication, and problem-solving skills
• Ability to interpret complex regulations and guide stakeholders

🎁 Benefits

• Opportunity to contribute to regulatory strategy in Canada
• Full-time role based in Canada
• Collaborative, cross-functional environment
• Professional development and exposure to evolving standards
• Projects across product development, registration, and lifecycle
• Inclusive, diverse workplace with growth opportunities