Sr. RA Associate Consultant

📋 Description

• Collaborate with regulatory project teams to review, create, and update technical documentation in
• Maintain a strong understanding of EU MDR and relevant global medical device regulations
• Identify applicable regulatory requirements and submission considerations and apply them
• Draft, create, and update technical documentation in collaboration with Regulatory Affairs subject
• Retrieve, review, and consolidate technical file and design documentation from PLM or similar
• Create and upload bookmarks, indexes, and supporting documentation into PLM systems through

🎯 Requirements

• Hold a Bachelor’s degree, preferably in life sciences or a related discipline.
• Bring at least 2 years of professional Regulatory Affairs experience with a focus on EU MDR.
• Possess mandatory knowledge of EU MDR, ISO 13485, and FDA medical device regulations.
• Demonstrate strong working proficiency with Microsoft Office applications, including Word, Excel
• Be comfortable working independently on projects of varying scope, evaluating multiple factors and
• Demonstrate strong organizational and planning skills, with exceptional attention to detail and the

🎁 Benefits

• Competitive compensation of $40–$44 CAD per hour.
• 12-month contract with potential for extension.
• Remote working opportunity in Canada.
• Client-facing experience within a global regulatory and clinical development environment.
• Direct exposure to EU MDR and other international medical device regulatory requirements.
• Opportunity to work on technical documentation, regulatory submissions, quality control, and