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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This webinar will provide an Industry perspective on the impact of EU- MDR/ IVDR changes, as well as an overview of relevant Health Canada requirements.
Members: $0 | NonMembers: $25
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Regulatory affairs professionals and managers
Suzie is VP Regulatory, she has eighteen years of experience within BSI. She also has the opportunity to represent all Notified Bodies as one of the Chairs of NBCG-Med and Vice-President of TeamNB.
In her current role, she develops strategies, policies and processes for the Medical Devices team to ensure compliance with global regulatory requirements.
Prior to Suzie’s work at BSI she completed a Bachelor Degree and Masters in Science (University of Waterloo) and a Doctorate in Engineering (University of Oxford).
Suzie has worked in orthopaedic hospitals in Australia, Canada, Japan, UK and the USA, testing joint replacement implants, spinal and fracture fixation systems. She has also lead clinical investigations on orthopaedic implants.
David Boudreau has a biochemistry degree and a chemical engineering degree with honour, both from the University of Ottawa. While at university he did lab work at the National Research Council (NRC). Once he completed his studies, he worked for three years at i-STAT, as a Process Engineer in the manufacturing of medical devices for blood tests. He then joined the Patent Office at the Canadian Intellectual Property Office (CIPO) in January 2004, as a Patent Examiner, where he specialized in diagnostic methods, and devices thereof.
In March 2010, he joined the Office of the Commissioner of Official Languages (OCOL), as Special Advisor. In January 2014, he was promoted to the position of Assistant Director and was in charge of external audits and evaluations. As OCOL is an Agent of Parliament, he was exposed to the wiring of the government.
In November 2014, he came back to the Patent Office as Director, where he was responsible for a group of 145 employees in the sectors of Quality, IT, Training and Operations. In January 2018, he has taken on new challenges at Health Canada, as Executive Director of the Medical Devices Bureau, and then in January 2020, the role of Director General of the Medical Devices Directorate.
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