Job Description
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 As...
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 As...