Lead global regulatory strategy for BD medical devices and software, applying regulatory expertise, technical files, and impact assessments in Mississauga.

The Staff Specialist, Regulatory Affairs supports MMS Dispensing products across recent product development, sustaining, and end of life activities. Reporting to the Senior Manager, this role addresses U.S. and worldwide requirements, including FDA Medical Device Regulations and EU-MDR. The position combines regulatory strategy, submissions, quality systems, and cross-functional collaboration.

Key Responsibilities:

- Develop global regulatory strategy for dispensing products and software
- Lead compliance with FDA regulations and EU-MDR
- Execute technical file creation and remediation




- Prepare regulatory impact assessments for design changes
- Resolve issues and communicate responses to internal customers

Requirements:

- Bachelor’s degree in biology, engineering, or related science
- Five to seven years of medical device regulatory experience
- Software as a Medical Device focus strongly preferred
- Regulatory strategy and submission management skills
- Strong communication, organization, and collaboration abilities

Bring global medical device compliance, software knowledge, and regulatory strategy skills to BD’s MMS Dispensing portfolio.

📌 Global Medical Device Regulatory Affairs Specialist (Mississauga)
🏢 Becton Dickinson
📍 Mississauga