- Build and maintain collaborative working relationships with local/global business partners by ensuring effective and timely communication of regulatory issues, project status and timelines.
- Execute appropriate regulatory submission for product lifecycle management for medical devices currently marketed in Canada.
- Management of multiple regulatory projects by ensuring accurate tracking and documentation of activities.
- Accurate documentation and record keeping of all assigned regulatory activities.
- BS in life sciences is required; advanced degree (MSc or PhD) an asset.
- Sound knowledge of Food and Drugs Act and Medical Device Regulations and relevant policies and guidelines is required.
- Excellent verbal and written communication skills.
- Strong project management and time management skills.
- Detail-oriented and ability to multi-task.
- Excellent analytical problem-solving skills.
- Proficient with Microsoft Office tools.
- Completion of Post Graduate training in Regulatory Affairs - RAC (Regulatory Affairs Certification) preferred.
- Regulatory affairs experience in preparation of medical device submissions is preferred.
- Experience in managing regulatory submission activities is preferred.
Regulatory Affairs AssociateMarkham, ON, Canada
Kelly Services just received an opening for a Regulatory Affairs Associate in Markham, Ontario. This is a one-year assignment, 37.5 hours per week.
If you are interested, please send me a recent MS Word resume. We are limited to two submissions at this time so please don’t delay!
Category: Biotechnology & Pharmaceutical
Reference ID: CA768JGR000039
Date Posted: 11/10/2019