Regulatory Affairs Specialist Consultant (Medtech)

TL;DR

Regulatory Affairs Specialist Consultant (Medtech): Preparing, reviewing, and submitting technical documentation for medical devices with an accent on Health Canada compliance and regulatory standards. Focus on managing product changes, ensuring cGDP compliance, and supporting cross-functional teams in a hybrid environment.

Location: Must be based in or able to commute to Mississauga, ON, Canada (Hybrid: 2-3 days/week)

Salary: $1 - $2 CAD

Company

hirify.global is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Prepare and support medical device registration submissions and post-market regulatory activities.
• Review product changes and manage necessary regulatory submissions.
• Prepare and review regulatory documentation including letters of authorization, cover letters, and power of attorney.
• Ensure compliance with current Good Documentation Practices (cGDP) including proofreading and record-keeping.
• Maintain tracking tools to ensure data traceability and regulatory compliance.
• Communicate effectively with internal and external teams regarding project status and technical inquiries.

Requirements

• Minimum of three years of experience in regulatory affairs preparing technical documentation for Health Canada medical device regulations.
• Strong understanding of EU MDR and ISO13485 standards.
• Proficiency in Microsoft Office suite.
• Excellent written and verbal communication skills.
• Strong organizational, planning, and critical thinking skills.
• Ability to work in a team environment with minimal supervision.

Culture & Benefits

• Opportunity to work with a major consumer products client while maintaining the security of a global CRO.
• Focus on professional development and continuous training.
• Supportive and inclusive company culture with low turnover rates.
• Commitment to diversity and barrier-free recruitment processes.