07 Nov
|
BD
|
Mississauga
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 standards
- Support global strategy for MMS Dispensing products and software
- Assure QSMR requirements are consistently followed from Regulatory Affairs
- Provide timely communication and responses to internal customers
- Drive continuous improvement in processes and customer satisfaction
Requirements:
- Bachelor’s degree in biology, engineering, or science-related discipline
- Minimum five to seven years’ medical device Regulatory Affairs experience
- Advanced degree preferred
- Knowledge of SAP, RIM, or related information systems
- Robust organizational, submission, and deadline management skills
Apply global medical device regulatory knowledge, standards interpretation, and project coordination across BD’s MMS Dispensing products.
📌 Global Medical Device Regulatory Specialist (Mississauga)
🏢 BD
📍 Mississauga