Regulatory Affairs Assistant

Full time, Permanent

The Regulatory Affairs Assistant will work closely with the Regulatory & Quality Manager and Quality Coordinator assisting with day-to-day operations of the Regulatory and Quality department.

What You’ll Be Responsible For

  • Prepare documents required for regulatory/quality files
  • Audit Preparation
  • Assisting Quality Coordinator and Regulatory & Quality Manager
  • Aid in corrective & preventive actions (CAR generated following all audits)
  • Updates Technical Files (testing, forms, literature, labels, IFU, etc.), Quality Manual and production requests
  • Aids in coordinating, compiling and maintaining, data for Quality Management objectives
  • Aids with FDA, UDI registration
  • Review and Coordinate General email account inquiries
  • Aids in analyzing customer quality/regulatory questionnaires
  • Completes other general regulatory duties

What You’ll Bring to the Team

  • Fluent with ISO functionality & Standards (ISO 13485, MDSAP, CE, FDA)
  • Detail oriented and skilled to work independently and as a team
  • Excellent Microsoft office experience, Excel & Outlook focused
  • Ability to learn new software quickly
  • Strong organization skills
  • Ability to multitask
  • Time Management
  • Comfortable with Medical Terminology
  • Research driven
  • Excellent interpersonal, verbal, and written communication skills grammar and composition
  • Demonstrate initiative and good judgment
  • Have a positive attitude, disciplined work ethic and a keen desire to learn
  • Strong typing skills

Why You’ll Love Working Here

  • Dental care
  • Vision care
  • Disability insurance
  • Extended health care
  • Life insurance
  • RRSP match
  • Free snacks

Additional Information

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