Quality and Regulatory Specialist

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 our own machine learning & deep learning models. The key Vitaliti differentiator is the ability to gather very accurate telemetry from easy to use, continuous and spot monitor devices that can immediately be analyzed by modern artificial intelligence systems.

Responsibilities

• 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
• Ensure QMS processes and documentation conform to applicable standards (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 PDLC processes and design principles fulfill regulatory requirements
• Perform gap analysis between existing processes and documentation
• Support internal and external audits
• Assess compliance with standards and regulations and identify remedial actions
• Interface with Ethical Research Boards and participating academic or health institutions during studies and trials

Requirements

• 5+ years of experience in a regulated quality environment, preferably medical device development
• 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
• Ability to work independently and drive tasks to completion
• Strong attention to detail and communication skills