Senior Regulatory Specialist - Medical Devices (Ontario)

Senior Regulatory Specialist - Medical Devices (Ontario)

23 Aug
|
Socket.dev
|
Ontario

23 Aug

Socket.dev

Ontario

Elevate your career at Johnson & Johnson as a Senior Regulatory Affairs Specialist located in Markham, Ontario, focusing on compliance for advanced medical technologies.

Your principal mission will be to craft and execute regulatory strategies for complex Class III and IV medical devices, driving quality and compliance from pre-market to post-marketing. You will work with health authorities and maintain vital relationships that support effective product introductions and quality system enhancements.

Key Responsibilities:
• Lead regulatory strategies for complex medical devices
• Manage the regulatory lifecycle and product approvals
• Conduct and support compliance audits and inspections
• Mentor junior staff in regulatory best practices
• Optimize Quality Management System processes

Requirements:
• Bachelor’s in Life Science, Engineering, or related field
• Minimum 3-5 years in Regulatory Affairs for Medical Devices
• Expertise in managing health authority inspections
• Excellent skills in problem-solving and communication
• Knowledge of ISO 13485 and quality regulations

Drive regulatory excellence at Johnson & Johnson as part of their creative MedTech team.
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📌 Senior Regulatory Specialist - Medical Devices (Ontario)
🏢 Socket.dev
📍 Ontario

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