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. If you naturally identify gaps, ask thoughtful questions, and take ownership of documentation accuracy and process alignment, you will excel in this role.

You will work closely with cross-functional teams to maintain controlled documentation, support compliance with applicable standards, assist with gap assessments, and contribute to continuous improvement initiatives. The ideal candidate is highly organized, confident navigating ISO requirements, and comfortable working with a high level of precision and accountability. Experience working within ISO regulated environments, particularly ISO 13485 is required. The role is hands-on and requires onsite work in Kitchener, Ontario.

What You’ll Do 

• Support communications with relevant regulatory bodies in North America and the EU to support clinical trials and device licensing/clearance.
• Maintain internal quality processes, including shipping/receiving, incoming inspections, device assembly, and product releases.
• Be responsible for ensuring that QMS processes and documentation conform to applicable standards required for regulatory approval (Health Canada, FDA, CE)
• Administer and assist in the development of standards and workflows within the QMS
• Interface with the R&D team to ensure that PDLC processes and design principles fulfill anticipated regulatory requirements
• Perform gap analysis between existing processes and documentation and manage the updating process
• Support internal and external audits.
• Assess compliance with standards and regulations and identify remedial actions where necessary
• Interface with Ethical Research Boards and participating academic or health institutions during studies and trials

Who You Are

• 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
• Comfortable collaborating with technical teams in a structured environment