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.
Regulatory Affairs Assistant
Full time, Permanent
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
