Global Medical Device Regulatory Affairs Specialist

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 new 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 softwareLead compliance with FDA regulations and EU-MDRExecute technical file creation and remediationPrepare regulatory impact assessments for design changesResolve issues and communicate responses to internal customersRequirements:
Bachelor’s degree in biology, engineering, or related scienceFive to seven years of medical device regulatory experienceSoftware as a Medical Device focus strongly preferredRegulatory strategy and submission management skillsStrong communication, organization, and collaboration abilitiesBring global medical device compliance, software knowledge, and regulatory strategy skills to BD’s MMS Dispensing portfolio.
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