Course Lecturer -BMDE 654 Biomedical Regulatory Affairs - Medical Devices

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COURSE DESCRIPTION

The Department of Biomedical Engineering of the Faculty of Medicine, McGill University, is seeking applications for a Course Lecturer for the 2025-2026 academic year to teach BMDE 654 Biomedical Regulatory Affairs - Medical Devices (3 credits)

Course overview: Biomedical Engineering : Regulatory strategies and quality management systems are critical for medical device development. This course provides an overview of regulatory requirements, and familiarize students with the important ISO and IEC standards pertaining to medical device development. This course will provide biomedical engineers with 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.

RESPONSIBILITIES

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.

OTHER MAIN RESPONSIBILITIES INCLUDE:

Preparation of course lectures and teaching materials

Preparation of assignments, tests and grading rubrics

Participation in curricular discussions

Hold regular office hours

TEACHING QUALIFICATION 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 14+71:2007, and IEC 62304:2006 standards, and FDA’s Quality System Regulations (21CFR820).

Education

Bachelor of Science, Engineering, or Arts

Experience

More than 5 years in medical device quality management & regulatory affairs

Other

Fluency in English and French (written and verbal) preferred

Applications for this course will be accepted until: June 14, 2025

This posting will expire at 00:00 am the day of the deadline to apply. You have until midnight the day before the deadline to apply to submit your application.

Disclaimer

Please note that, government directives permitting, it is anticipated that most courses will be taught in person. Should government restrictions prohibit in-person teaching, courses will revert to remote teaching. In the event of such a change, Course Lecturers will be advised without delay. Course Lecturers may be required to prepare and deliver teaching material suited to a remote/online teaching environment using a virtual learning platform (e.g., Zoom, WebEx) and the McGill myCourses learning management system. Training and assistance on remote teaching is available through Teaching and Learning Services (TLS) . Course Lecturers are encouraged to record their lectures.

Hiring Unit:

Biomedical Engineering

Course Title:

Biomedical Regulatory Affairs - Medical Devices

Subject Code:

BMDE 654

Location:

Duff Medical Building

Schedule:

Thursdays 16:05-18:55

Deadline to Apply:

2025-06-13

McGill University hires on the basis of merit and is strongly committed to equity and diversity within its community. We welcome applications from racialized persons/visible minorities, women, Indigenous persons, persons with disabilities, ethnic minorities, and persons of minority ****** orientations and gender identities, as well as from all qualified candidates with the skills and knowledge to productively engage with diverse communities. McGill implements an employment equity program and encourages members of designated groups to self-identify. Persons with disabilities who anticipate needing accommodations for any part of the application process may contact, in confidence,

accessibilityrequest.hr@mcgill.ca

.

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