Support BD’s on-site healthcare operations in Mississauga through regulatory compliance, quality systems, and post-market medical device activities.
This Staff Regulatory Affairs Specialist provides regulatory support for BD products entering and remaining in Canadian markets. The approximately 21-month assignment spans medical devices and natural health products, with responsibilities across compliance, licensing, quality systems, and inspections.
You will collaborate with regional and cross-functional teams, assist with recalls and audits, and lead regulatory activities connected with product changes. The position also calls for detailed communication, adaptability, organization, and knowledge sharing with team members.
Key Responsibilities:
- Perform current product activation and post-market change assessments
- Review advertising and promotional materials for regulatory requirements
- Support recalls, Health Canada inspections, and corporate audits
- Assist with SOP maintenance and internal audit activities
- Mentor team members through knowledge, advice, and resources
Requirements:
- Life sciences or engineering Bachelor of Science degree
- Regulatory Affairs experience in the medical device industry
- Seven-plus years of relevant regulatory experience
- Medical device license application preparation experience
- Excellent communication, collaboration, and attention to detail
Combine compliance knowledge, quality systems experience, and team guidance to advance BD medical device regulatory work.