Our client, a Medical Devices/Healthcare company, is looking for a Regulatory Affairs Specialist for their Mississauga, ON location.
Responsibilities:
- Intake of product complaints originating within Canada and assessing complaints for reportability to Health Canada
- Accessing EtQ and completing Canada reportability decision trees
- Conducting follow-ups with complainants to capture critical information needed for reporting assessments and details required for Health Canada
- Reporting preliminary and final incident reports to Health Canada
- Keeping all associated trackers up to date (including local SharePoint and EtQ up to date with copies of all communications and submitted reports)
- Requesting and filling out IRAs / RGAs for product returns from the field and onto the manufacturer for investigation
Requirements:
- Bachelor's Degree and 2 years of relevant experience, or Associate's Degree and 4 years of relevant experience, or High School Diploma or Equivalent and 6 years of relevant experience