Lead global regulatory strategy for BD medical devices and software while supporting new product development, sustaining, and end-of-life activities on site. Work at BD’s Mississauga location with strong regulatory expertise and cross-functional collaboration.

As Staff Specialist, Regulatory Affairs, you will report to the Senior Manager of Regulatory Affairs. You will support MMS Dispensing products, including non-medical and medical devices, software, and accessories globally. The work spans FDA Medical Device Regulations, EU-MDR, Technical Files, QSMR requirements, and regulatory impact assessments. This role requires five to seven years of directly related medical device Regulatory Affairs experience.

Key Responsibilities:

- Develop and implement global regulatory strategy for MMS Dispensing products
- Lead compliance efforts for FDA regulations and EU-MDR




- Execute Technical File creation and remediation with cross-functional teams
- Draft regulatory impact assessments for design control changes
- Resolve and escalate regulatory and compliance issues appropriately

Requirements:

- Bachelor’s degree in biology, engineering, or related science discipline
- Five to seven years of medical device Regulatory Affairs experience
- SaMD focus strongly preferred
- RAPS RAC certification preferred
- Strong regulatory strategy, communication, and project management skills

Bring global regulatory strategy, medical device expertise, and exact submission management to BD’s MMS Dispensing portfolio.

📌 Staff Regulatory Affairs Specialist (Mississauga)
🏢 BD
📍 Mississauga