Regulatory Affairs Specialist, Digitalization
$110,200–$176,400 year
On-site · Franklin Lakes, New Jersey, United States
Job Summary
Regulatory Affairs Specialist, Digitalization drives the digital regulatory platform strategy across BD’s Global Businesses and Regions, overseeing the eIFU Qarad system, coordinating with central, BU and regional teams to meet user needs, align with global regulatory strategies, and advance a flexible, scalable digital Product Information Management system through cross-functional collaboration and agile problem-solving. The role emphasizes supporting global RA digital platforms, managing digital regulatory portfolio, defining key goals, and leveraging digital tools to improve compliance, efficiency, and harmonization, while partnering with Regulatory Leadership and senior stakeholders. Requires collaboration across IT and regulatory teams, knowledge of GxP, CSV, and SDLC, and strong communication and organizational skills to drive high-impact regulatory initiatives.
Required Qualifications
- Bachelor’s degree in science, engineering, or technology discipline required
- Minimum of 3 years in Medical Device industry
- Minimum of 5 years working with IT to launch and maintain systems following GxP, Computer Systems Validation (CSV) and Software Development Lifecycle (SDLC) standards
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