The Senior Regulatory Affairs Specialist will develop complex global regulatory strategies and prepare submissions for medical devices in the U.S. and Europe
Job Summary
The Senior Regulatory Affairs Specialist will develop complex global regulatory strategies and prepare submissions for medical devices in the U.S. and Europe.
Responsibilities include leading cross-functional teams in preparing submissions, acting as a liaison with regulatory bodies, and assessing changes to device modifications.
BD is a global medical technology company advancing health through discovery, diagnostics, and care delivery, fostering a culture of learning, growth, and making the world a better place.
Matching Summary
The Senior Regulatory Affairs Specialist will develop complex global regulatory strategies and prepare submissions for medical devices in the U.S. and Europe.
Skills & Requirements
Must-have
Develop complex global regulatory strategies
Prepare regulatory submissions for US and Europe
Support product development process
Lead cross-functional teams
US and European medical device regulations
Technical writing skills
Proficient in Microsoft Office Suite
Nice-to-have
Mentorship to junior associates
Advancing the world of health
Culture of excellence
Human element across global teams
Key Requirements
Bachelor of Science required
Minimum 5 years experience in Regulatory or Quality
Experience with medical devices
Experience in product registration, compliance, or quality systems