Global Medical Device Regulatory Specialist

Support global regulatory strategy for BD’s MMS Dispensing portfolio, covering medical devices, software, accessories, and international standards. This primarily on-site Mississauga position emphasizes FDA, EU-MDR, and Technical File expertise.The Staff Specialist, Regulatory Affairs, reports to the Senior Manager of Regulatory Affairs and supports products throughout development, sustaining, and end-of-life activities. You will monitor regulatory requirements for the United States and rest of world, interpret standards, and lead compliance initiatives. Success requires organized project execution, strong written and verbal communication, and the ability to influence without direct authority.Key Responsibilities:
Monitor and interpret regulatory requirements and international standardsSupport global strategy for MMS Dispensing products and softwareAssure QSMR requirements are consistently followed from Regulatory AffairsProvide timely communication and responses to internal customersDrive continuous improvement in processes and customer satisfactionRequirements:
Bachelor’s degree in biology, engineering, or science-related disciplineMinimum five to seven years’ medical device Regulatory Affairs experienceAdvanced degree preferredKnowledge of SAP, RIM, or related information systemsStrong organizational, submission, and deadline management skillsApply global medical device regulatory knowledge, standards interpretation, and project coordination across BD’s MMS Dispensing products.
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