Lead global regulatory strategy for BD medical devices and software while supporting new 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
- Strong regulatory strategy, communication, and project management skills
Bring global regulatory strategy, medical device expertise, and precise submission management to BD's MMS Dispensing portfolio.
Staff Regulatory Affairs Specialist in Mississauga employer: BD
Waters Corporation is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for Senior Project Managers to thrive. With a commitment to employee growth, you will have access to continuous learning opportunities and the chance to work on groundbreaking projects that improve healthcare outcomes. Located in vibrant regions like British Columbia, Alberta, and Ontario, you will enjoy a dynamic work environment that values face-to-face collaboration and supports your professional journey.
