Regulatory Affairs
New Product Development
Develop Regulatory Strategies for successful Medical Device registrations
Generate/review regulatory documentation to increase probability of registration success
Prepare teams for FDA meetings to ensure targeted discussions
Pressure-test cross-functional assumptions/strategies
Acquisitions/Divestitures
RA representative on Business Development Team to assess potential acquisition
Create regulatory information dossier to support potential divestiture
Training/Coaching
Programs for businesses to demystify the RA Black Box
Train teams on effective communication with regulators
Mentor/Coach high potential RA Talent to evolve into long term Business Partners