Nitin Rajan
VP of R&D | Experienced Leader in Biosensing & Diagnostics
- Role
- Director, Research and Development at Avails Medical, Inc
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Nitin Rajan
I build diagnostic platforms — from first scientific principles through FDA clearance and…
Experience
Director, Research and Development
Jan 2021 — Present
Directed the development and characterization of sensor, algorithm and system performance for an IVD FDA Class II device based on electrochemical sensing of microorganisms. • Oversaw the development of the Avails eQUANT system including consumable, instrument and software and firmware. Followed all the relevant regulatory standards and guidelines for Class II medical devices (510k for an IVD device), including ISO13845, ISO14971, IEC61010 & IEC60601. • Generated clinical/analytical study protocols as well as data management plans, per FDA guidance (Q-submission) and requirements. • Put together several grant proposals (i.e. SBIR/STTR from NIH and NSF) leveraging the Avails sensor technology and awarded up to $2.5M Carb-X grant to aid in the global fight against antimicrobial resistance.
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.