Course Lecturer -BMDE 654 Biomedical Regulatory Affairs - Medical Devices

McGill University • Montreal, QC

3d • Onsite

About The Position

The Department of Biomedical Engineering of the Faculty of Medicine, McGill University, is seeking applications for a Course Lecturer for the 2026-2027 academic year to teach BMDE 654 Biomedical Regulatory Affairs - Medical Devices (3 credits). This course provides an overview of regulatory requirements and familiarizes students with important ISO and IEC standards pertaining to medical device development. It aims to give biomedical engineers an understanding of the regulatory and quality requirements to translate a medical device idea into a commercial product, and will draw upon the expertise of invited speakers currently working in the medical devices industry.

Requirements

• Understand the FDA’s and Health Canada’s requirements for medical devices.
• Understand best practices required for timely regulatory clearance and entry of medical devices into USA and Canada markets.
• Understand the critical role of quality systems and effective process management in the innovation process.
• Understand quality management definitions, concepts, and guidelines.
• Understand the requirements of the ISO 13485:2003, ISO 14971:2007, and IEC 62304:2006 standards, and FDA’s Quality System Regulations (21CFR820).
• Bachelor of Science, Engineering, or Arts
• More than 5 years in medical device quality management & regulatory affairs
• Fluency in English and French (written and verbal) preferred

Responsibilities

• Preparation of course lectures and teaching materials
• Preparation of assignments, tests and grading rubrics
• Participation in curricular discussions
• Hold regular office hours
• Preparing the students with the required knowledge, facilitating classroom discussions, assessing and evaluating student performance and preparing students to be successful leaders in their profession.

What This Job Offers

• Career Level: Senior