Quality and Regulatory Specialist

We are seeking a detail-oriented and self-driven Quality and Regulatory Specialist to support and strengthen our quality and regulatory processes within a regulated medical device environment. This role is ideal for a Quality Management professional who takes initiative, operates independently, and thrives in structured, standards-based environments.

Requirements

• 5+ years of experience working within a regulated quality environment, preferably in medical device development and commercialization
• Bachelor’s degree in engineering with P.Eng. designation
• Practical experience maintaining or supporting a Quality Management System
• Working knowledge of ISO 13485 and or ISO 9001 requirements
• Strong documentation control and process organization skills
• Demonstrated ability to work independently and drive tasks through to completion
• Strong attention to detail with the ability to identify inconsistencies or gaps in documentation
• Clear written and verbal communication skills