Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions
Job Summary
Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions.
The Staff Regulatory Affairs is part of the Miami Regulatory Affairs team and will support new product development, global registrations, advertising and promotional materials, product labeling, post market regulatory compliance and adapting to new/changing regulatory requirements.
Apply Danaher Business System (DBS) tools to drive compliant and effective processes; improve capability to support growth.
Matching Summary
Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions.
Skills & Requirements
Must-have
IVD reagents and systems global registration
US submissions (510ks, Q-Subs)
EU Technical documentation (IVDR)
ROW documentation (technical dossier, STED)
Product lifecycle management
Danaher Business System (DBS) tools
Nice-to-have
Critical thinker
Acts decisively
Manages changing conditions
Systemic view of process improvement
Organized and thorough
High level of initiative
Key Requirements
8-10 years' experience in regulated medical device/diagnostic industry
Bachelor's degree in life sciences or engineering
Demonstrated experience negotiating regulatory strategies with FDA
Knowledge of domestic and international quality systems