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Regulatory Affairs Professional
- Location Oakville
- Job type Contract
- Salary CA$40 - CA$50 per hour
- Discipline Advanced Manufacturing
- Reference JOB-21102_1641998728
Role: Regulatory Affairs Professional
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.