Title: Regulatory Affairs Specialist Duration: 7+ Months Location: Mississauga, ON (L5N 5N3) Work Model: 8:30 AM from 4:30 PM, Monday to Friday
Role Overview The Regulatory Affairs Specialist will be responsible for managing product complaints originating within Canada, assessing complaints for reportability to Health Canada, completing required regulatory reporting, maintaining complaint-related records and trackers, and coordinating product returns for manufacturer investigation. The role requires attention to detail, regulatory awareness, effective communication, and the ability to follow established reporting and documentation processes.
Key Responsibilities
Intake product complaints originating within Canada and assess complaints for reportability to Health Canada.
Access EtQ and complete Canada reportability decision trees to determine appropriate regulatory actions.
Conduct follow-ups with complainants to obtain critical information required for reportability assessments and Health Canada submissions.
Prepare and submit preliminary and final incident reports to Health Canada in accordance with applicable requirements.
Maintain all associated regulatory trackers, including local SharePoint and EtQ, ensuring copies of communications and submitted reports are accurately documented.
Request and complete IRAs / RGAs for product returns from the field to the manufacturer for further investigation.
Required Qualifications
Bachelor's Degree and 2 years of relevant experience
Associate’s degree and 4 years of relevant experience,
High School Diploma or equivalent and 6 years of relevant experience
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is C$28.12/hr.
