Regulatory Affairs Specialist

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

• 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

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities