Regulatory Affairs Specialist, Digitalization

Responsibilities

• Support global Regulatory Affairs digital platforms for product information management.
• Oversee the digital regulatory platform portfolio, ensuring timely delivery and stakeholder alignment.
• Manage and maintain the eIFU Qarad system to support product information management.
• Partner with cross-functional teams (TGS, ISC, and Business Units) to implement digital solutions from concept to deployment.
• Collaborate with central, business unit, and regional partners to optimize systems using automation and digital tools.
• Support the Digital RA Portfolio and help define key driver goals with the Regulatory Leadership Team.

Requirements

• Bachelor's degree in science, engineering, or technology discipline.
• Minimum of 3 years of experience in the Medical Device industry.
• Minimum of 5 years of experience working with IT to launch and maintain systems following GxP, Computer Systems Validation (CSV), and Software Development Lifecycle (SDLC) standards.

Preferred Qualifications

• Master's degree in business, management, or a technology-related field.
• Minimum of 3 years of experience in Medical Device industry specifically within Regulatory Affairs or Quality Systems roles.

Benefits

• Competitive compensation including annual bonus and potential discretionary LTI bonus.
• Comprehensive health coverage including medical, dental, vision, and hospital care insurance.
• Financial well-being resources such as 401(k) plan, deferred compensation, and 529 College Savings Plan.
• Work-life balance programs including paid time off, parental leave, and educational assistance.
• Wellness programs covering mental health, nutrition, and physical therapy.

About the Company

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and we focus on providing transformative solutions across design, engineering, manufacturing, and marketing of MedTech products to improve healthcare outcomes globally.