Sr. Regulatory Affairs Specialist

Responsibilities

• Develop and execute international regulatory strategy for in vitro diagnostic (IVD) devices in markets outside of US and EU
• Generate, coordinate, and manage regulatory submission documents for new products, renewals, or changes
• Coordinate responses to regulatory agencies during the submission and approval process
• Represent Regulatory Affairs in cross-functional product development teams
• Support change management by evaluating design, manufacturing, and process changes for global regulatory impact
• Review analytical and clinical protocols to ensure appropriate data collection for submissions
• Review and approve labels, labeling, and promotional materials for compliance
• Manage and track international product registration in Regulatory Information Management (RIM) databases

Requirements

• Bachelor's degree in biological sciences, chemistry, or a related science
• Minimum 3 years of experience in the device, diagnostic, biologic, or pharmaceutical industry
• Knowledge of in vitro diagnostic regulatory requirements, GLP, and QSR
• Understanding of European quality system standards
• Strong project management and multitasking abilities
• Excellent verbal and written communication skills

Preferred Qualifications

• Experience with tech file preparation and approval
• Demonstrated ability to interpret new regulations and IVD requirements

About the Company

BD is one of the largest global medical technology companies in the world, advancing health by improving medical discovery, diagnostics, and the delivery of care.