The Senior Regulatory Affairs Specialist will lead the development of complex global regulatory strategies and prepare submissions to market medical devices in the U.S. and Europe
Job Summary
The Senior Regulatory Affairs Specialist will lead the development of complex global regulatory strategies and prepare submissions to market medical devices in the U.S. and Europe.
BD is one of the largest global medical technology companies, advancing health by improving medical discovery, diagnostics, and care delivery with a culture that supports learning and growth.
The role requires leadership in cross-functional teams, minimal supervision, and mentorship of junior regulatory associates while ensuring compliance with regulatory requirements throughout the product lifecycle.
Matching Summary
The Senior Regulatory Affairs Specialist will lead the development of complex global regulatory strategies and prepare submissions to market medical devices in the U.S. and Europe.
Skills & Requirements
Must-have
Regulatory strategy development
Medical device submissions
US FDA liaison experience
European Notified Bodies interaction
Knowledge of US and EU medical device regulations
Technical writing for regulatory submissions
Cross-functional team leadership
Nice-to-have
Global regulatory collaboration
Project management skills
Strong communication skills
Self-motivated and independent
Mentorship of junior associates
Proficiency in Microsoft Office suite
Demonstrated global perspective
Key Requirements
Bachelor of Science degree
Minimum 5 years regulatory or quality experience
Experience with medical device product registration