At Trudell Medical International ( TMI ), we pride ourselves on our passion for finding innovative and creative solutions which has enabled us to develop medical devices that continue to make a difference in the lives of people around the world.  Situated within a modern facility located in beautiful London, Ontario, TMI offers a comfortable work environment with a respectful and family-oriented culture.
 
As an employee of Trudell Medical International, not only will you contribute to the development of products at the cutting edge of medical device technology, but you will also have the opportunity to perform challenging work alongside a first-rate group of dedicated professionals.
 
We’re actively searching for our next leader to join us as Manager, Regulatory Affairs.
 
As a member of our growing Regulatory Affairs team, you will proactively support marketing and product development initiatives by providing strategic regulatory guidance.  You will provide accurate, relevant, and timely information internally and externally, and manage the implementation, maintenance and execution of TMI’s regulatory activities for all manufactured products.   And, you will ensure that all products and services meet required standards and regulatory requirements. 

• Do you have experience with FDA, CE, Health Canada clearance and approvals for Class 1 and Class 2 medical devices?

• Do you possess excellent oral and written communication skills, as well as technical writing skills?

• Do you have experience in quality management systems, such as ISO13485?

• Are you a university graduate with a degree in health, mechanical or manufacturing engineering or biomedical sciences?

• Do you have at least ten years of experience, in a highly disciplined, regulated environment, including at least five years of previous management experience in regulatory affairs or quality assurance?