Job Description

Description:
Key Responsibilities:


Support Canadian regulatory affairs submissions activities for Class II-IV in vitro diagnostics (IVD) medical devices for commercialization in Canada. Identify, analyze the medical device license application requirements, and prepare product-related regulatory applications to Health Canada. As required, respond to Health Canada's inquiries in a rational and timely manner.


Build relationships, and liaise with Client internal organizations (e.g. Business Lines) to plan and prepare product related regulatory activities.


Assist with assessing product changes (PCNs) for regulatory impact.


Assist with reviewing/approving promotional material against relevant Medical Device Regulations (MDRs).


Ensure creation of adequate documentation for audits/inspections, including updating of electronic department files, and initiate & escalate necessary activities if deviations are identified.


Carry out duties in compliance with established business policies.


Contribute to the regulatory affairs team effort and show awareness of expected responsibilities.


Perform other duties and projects as assigned.


Qualifications
The ideal candidate will possess effective English oral and written communication, time management, project planning and organizational skills. The candidate must also demonstrate a proven ability to work effectively within a team environment while satisfying individual responsibilities and objectives to meet rigorous deadlines with minimal supervision.


Additionally, the following qualifications and experience must be met:


Strong working knowledge of Health Canada's Food & Drugs Act, Medical Devices Regulations and associated guidance documents.


Experience in Class III-IV medical device submissions to Health Canada (IVD experience preferred).


BSc or higher (Science/Chemistry or Engineering preferred).


Should possess, or be working towards a Regulatory Affairs post-graduate degree diploma or certificate.

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