Duration: 01/17/2022 to 01/15/2023
Location: Oakville, ON
Hours: Monday - Friday 8 hours per day, 40 per week maximum
Rate: $40-$50/T4 - up to $60/if incorporated

Key Responsibilities

• 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.

Qualifications

• 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.