Quality and Regulatory Specialist

Responsibilities

• Support communications with regulatory bodies in North America and the EU for clinical trials and device licensing
• Maintain internal quality processes including shipping, receiving, inspections, and product releases
• Ensure QMS processes and documentation conform to Health Canada, FDA, and CE standards
• Administer and develop standards and workflows within the QMS
• Interface with R&D to ensure PDLC processes fulfill regulatory requirements
• Perform gap analysis and manage documentation updates
• Support internal and external audits
• Assess compliance and identify remedial actions
• Interface with Ethical Research Boards and academic/health institutions during trials

Requirements

• 5+ years of experience in a regulated quality environment, preferably medical devices
• 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
• Strong documentation control and process organization skills
• Ability to work independently and drive tasks to completion
• Strong attention to detail and communication skills

About the Company

Vitaliti Technologies Inc. is creating an ecosystem of unique, proprietary medical devices and software that generate high frequency biological signals, feeding large volumes of structured data to machine learning and deep learning models for remote automated monitoring and clinical trials.