Medical device regulatory expertise meets Canadian strategy at Johnson & Johnson in Markham, supporting complex Class III and Class IV products.
This Regulatory Affairs Specialist manages product lifecycles, submissions, and compliance for medical devices and combination products. The work includes Health Canada engagement, promotional review, and quality system activities. You will advise internal stakeholders and business partners.
Key Responsibilities: Develop Canadian strategies for Class III and Class IV devices
Manage regulatory activities from pre-market through post-marketing
Review promotional materials against corporate and Health Canada requirements
Guide stakeholders on pathways, submissions, recalls, and special access
Improve QMS processes, audits, CAPA,



and document management
Requirements: Bachelor’s degree in life, engineering, or physical science
Three to five years’ medical device or pharmaceutical experience preferred
Knowledge of Food and Drugs Act and Regulations required
Regulatory submission management experience required
Solid communication, technical writing, and collaboration skills required
Apply regulatory strategy, Health Canada knowledge, and quality systems expertise to advance medical device compliance in Markham.

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📌 Medical Device Regulatory Affairs Specialist (Ontario)
🏢 Brighter Signals
📍 Ontario