Lead global regulatory strategy for BD medical devices and software while supporting current 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
Solid regulatory strategy, communication, and project management skills
Bring global regulatory strategy, medical device expertise, and exact submission management to BD’s MMS Dispensing portfolio.