Quality System Specialist

Join Celestra Health Systems in Ottawa as a Quality System and Regulatory Affairs Specialist. This critical role focuses on managing FDA and EU regulations for innovative software medical devices.

In this position, you will implement and maintain our Quality Management System, ensuring compliance with industry standards like ISO 13485. You'll coordinate regulatory submissions for our Software as a Medical Device products while collaborating with cross-functional teams and quality consultants. Your contributions will help us navigate the complexities of regulatory frameworks within the medical technology sector.

Key Responsibilities:

• Develop and enhance the Quality Management System

• Prepare and track regulatory submissions to the EU and FDA

• Conduct quality training and support CAPA processes

• Manage document control processes and quality records

• Facilitate audits and inspections for regulatory compliance

Requirements:

• Bachelor’s degree in Quality Assurance or related field

• Experience with SaMD regulatory processes

• In-depth knowledge of ISO 13485 and FDA standards

• Strong analytical and problem-solving abilities

• Excellent communication skills in a cross-functional team

Utilize your regulatory affairs expertise to drive the success of Celestra Health's innovative technology in neurology.
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