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
- Strong communication, technical writing, and collaboration skills required
Apply regulatory strategy, Health Canada knowledge, and quality systems expertise to advance medical device compliance in Markham.
Medical Device Regulatory Affairs Specialist in Markham employer: Brighter Signals
At Johnson & Johnson, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work environment that fosters innovation and personal growth. Our commitment to employee development is matched by our dedication to diversity, ensuring that every team member feels valued and empowered to make a meaningful impact in the healthcare sector. With competitive compensation and a focus on collaboration, working as a Product Specialist in the beautiful regions of Central and Western Canada provides a unique opportunity to contribute to groundbreaking medical advancements while enjoying a supportive and engaging workplace culture.
