Clinical Regulatory Affairs Specialist Consultant

Take the next step in your regulatory career with ClinChoice Canada Inc. as a Clinical Regulatory Affairs Specialist Consultant. This hybrid role focuses on submitting and managing medical device documentation effectively.

The ideal candidate will bring over three years of regulatory affairs experience and an understanding of Health Canada and EU regulations. You will collaborate with cross-functional teams, ensuring documentation standards are met and that submissions are accurate and timely.

Key Responsibilities:
• Support medical device registration and post-marketing activities
• Review documentation for product modifications
• Prepare necessary letters and regulatory submissions
• Ensure adherence to good documentation practices
• Confer with teams to resolve technical inquiries

Requirements:
• At least three years of regulatory affairs experience
• Basic knowledge of ISO13485 and EU MDD/MDR
• P...