Duration: 01/17/2022 to 01/15/2023
Location: Oakville, ON
Hours: Monday - Friday 8 hours per day, 40 per week maximum
Support regulatory affairs submissions activities for Health Canada Class II-IV in vitro diagnostics (IVD) medical devices for commercialization in Canada.
Identify, analyze the requirements, and prepare product related regulatory submissions to Health Canada.
Interact with Siemens internal organizations (e.g. Business Lines) to plan and prepare product related regulatory activities.
Submit required product related regulatory documentation/information to Health Canada.
Initiate and escalate necessary activities if deviations are identified.
Ensure creation of adequate documentation for audits/inspections, including updating of electronic department files.
Contribute to the regulatory affairs team effort, awareness of expected responsibilities and value-add.
Carry out duties in compliance with established business policies.
Perform other duties and projects as assigned.
This position requires the ideal candidate to possess effective oral and written communication, time management, project planning and organizational skills. S/he must also demonstrate 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:
Solid working knowledge of Health Canada Medical Devices Regulations and associated guidance documents.
Must have experience in medical device submissions to Health Canada (IVD experience - preferred).
BSc or higher (Science or Engineering preferred).
Should possess or be working towards a Regulatory Affairs post-graduate degree diploma or certificate.