We are currently seeking a subject matter expert with 3 to 10 years of experience in the medical device industry, specifically with a focus on Canadian regulations, to volunteer for a crucial role in updating our "Medical Devices: Canadian Regulations" course.
This course aims to equip learners with a fundamental understanding of the regulatory requirements for medical devices in Canada but requires an update to incorporate the latest regulatory changes and best practices.
Course Overview:
This course offers comprehensive insights into:
- Health Canada's regulatory framework for medical devices.
- The process for investigational testing applications and medical device licence applications.
- Post-market surveillance and compliance requirements.
- Device classification rules, licence type selection, submission requirements, quality systems, and post-market obligations.
Volunteer Role Expectations:
The volunteer SME will:
- Conduct a thorough review of the current course material to ensure accuracy and relevancy.
- Identify necessary updates or overhauls to reflect the latest in Canadian medical device regulations, last updated in 2016
- Update the course to include new Health Canada guidelines and industry best practices.
- Enhance course comprehensiveness regarding classification, licensing, and post-market practices in Canada.
Volunteer Specifications:
- Must have 3 to 10 years of experience in the medical device industry, particularly in regulatory affairs or compliance roles focusing on Canadian regulations.
- Should have an extensive understanding of Health Canada’s regulatory requirements, submission processes, and post-market activities.
- Must demonstrate strong research and analytical skills for effectively updating educational content.
- Should be passionate about education, with a commitment to sharing knowledge and best practices within the industry.
Key Details:
- Number of Volunteers Needed: One
- Incentive: Recognition for your contribution and a certificate of appreciation will be provided.
This volunteer opportunity is a chance to make a lasting impact on professionals navigating the regulatory landscape of the medical device industry in Canada. By lending your expertise, you will help ensure that the course remains a relevant, accurate, and invaluable resource.
If you have the required experience and are interested in contributing to this important educational project, please submit your resume and a brief statement of interest, highlighting your specific experience with Canadian medical device regulations.
Join us in this rewarding endeavor to update and improve our Medical Devices: Canadian Regulations course. We eagerly await your expertise and enthusiasm for this project!