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Nikhita Medi Email & Phone Number

Regulatory Affairs Manager at Dentsply Sirona at Dentsply Sirona
Location: New York, New York, United States 7 work roles 2 schools
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Current company
Dentsply Sirona
Role
Regulatory Affairs Manager at Dentsply Sirona
Location
New York, New York, United States
Company size
10 employees

Who is Nikhita Medi? Overview

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Quick answer

Nikhita Medi is listed as Regulatory Affairs Manager at Dentsply Sirona at Dentsply Sirona, a company with 10 employees, based in New York, New York, United States. AeroLeads shows a matched LinkedIn profile for Nikhita Medi.

Nikhita Medi previously worked as Regulatory Affairs Manager at Dentsply Sirona and Regulatory Affairs Specialist at Bovie Medical Corporation. Nikhita Medi holds Master’S Degree, Regulatory Affairs For Drugs Biologics And Medical Devices from Northeastern University.

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Dentsply Sirona

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Profile bio

About Nikhita Medi

I have an extensive graduate course work and industry experience in Regulatory Affairs for Medical devices.My technical skills:Regulatory skills: Pre – Market Notification {510(k)} Submission, QSR (Quality System Regulations), Risk Management, IDE, HDE (Humanitarian Device Exemption), BLA, IND, NDA, ANDA submissions, ICH guidelines GMP, GCP, GLP, 21 CFR 200-800, 820, 21 CFR 50, ISO 13485, ISO 14971, ISO 31000.Operating Systems: Windows, MacTools/Software: MS Office Suite, MS Project, Adobe Acrobat, ISI Toolbox and PubMed

Current workplace

Nikhita Medi's current company

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Dentsply Sirona
Dentsply Sirona
Regulatory Affairs Manager at Dentsply Sirona
York, Pennsylvania
Website
dentsplysirona.com
Employees
10
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7 roles

Nikhita Medi work experience

A career timeline built from the work history available for this profile.

Regulatory Affairs Manager

Current
Dentsply Sirona

Charlotte, North Carolina, US

Dec 2019 - Present

Regulatory Affairs Specialist

Bovie Medical Corporation
Jun 2018 - Oct 2019

Regulatory Affairs Specialist

Zimmer Biomet

Warsaw, Indiana, US

Mar 2017 - Mar 2018

Regulatory Foundations, Ethics And Law Intern

The Harvard Clinical And Translational Center
  • Provided translation services and drafted educational brochures for research subjects (Drug Research, Telemedicine, Clinical Care vs. Research).
  • Conducted numerous literature reviews to support manuscript preparation, posters and publications.
  • Organized all the regulatory documents and participated in the Regulatory Review Meetings every month.
  • Performed audits on all the educational brochures for research subjects.
  • Updated the Annotated Bibliography on risk assessment for the Social Behavioral Education Research Subcommittee.
  • Provided administrative support for different regulatory committees including IND/IDE and QA/QI and IRB/IT Task force.
Sep 2016 - Dec 2016

Regulatory Affairs Analyst

Blumea Therapeutics Pvt. Ltd.
  • Knowledge of FDA, EMA, ICH guidelines and understanding the IRB, Research regulations, compliance and Clinical trial application process
  • Assisted in the preparation and publication of regulatory submissions using eCTD as required.
  • Maintained Regulatory records and other FDA correspondences files.
Jun 2013 - May 2014

Intern

Vignan Institute Of Pharmaceutical Sciences
  • Worked in a group project on Evaluation of Anti microbial activity of the plant Mimosa pudica.
  • Compared the Anti microbial activity of the plant extract and the standard streptomycin on different species of bacteria.
Jan 2013 - Apr 2013

Industrial Trainee

Dr. Reddy’S Laboratories

New Delhi, IN

  • Attended a 30 days training program in Quality Assurance at Dr. Reddy’s Laboratories.
  • Performed different laboratory testing like sterility, stability, disintegration and distribution of components, containers, in-process materials, packaging materials and drug products using validated methods as per.
Jun 2012 - Jul 2012
Team & coworkers

Colleagues at Dentsply Sirona

Other employees you can reach at dentsplysirona.com. View company contacts for 10 employees →

RT Ruiz Teresa Ruiz Teresa Colleague at Dentsply Sirona Puerto Rico, Puerto Rico View → MF Michiel Fraikin Michiel Fraikin Colleague at Dentsply Sirona Diepenbeek, Flemish Region, Belgium, Belgium View → MR Martina Räbiger Martina Räbiger Colleague at Dentsply Sirona Petershagen, North Rhine-Westphalia, Germany, Germany View → HA Helene Aleros Helene Aleros Colleague at Dentsply Sirona Greater Gothenburg Metropolitan Area, Sweden View → YC Yamen Chaban Yamen Chaban Colleague at Dentsply Sirona United Kingdom, United Kingdom View → FF Florencia Fitte Florencia Fitte Colleague at Dentsply Sirona Auburndale, Massachusetts, United States, United States View → JG Jack Grant Jack Grant Colleague at Dentsply Sirona Greater Chicago Area, United States, United States View → CR Cathy Roth Cathy Roth Colleague at Dentsply Sirona York, Pennsylvania, United States, United States View → MR Marc Romero Sanchez Marc Romero Sanchez Colleague at Dentsply Sirona Frankfurt Rhine-Main Metropolitan Area, Germany, Germany View → DL Diego Leoncio Alves Diego Leoncio Alves Colleague at Dentsply Sirona Americana, São Paulo, Brazil, Brazil View →
2 education records

Nikhita Medi education

Master’S Degree, Regulatory Affairs For Drugs Biologics And Medical Devices

Northeastern University

Bachelor’S Degree, Pharmaceutical Sciences

Jawaharlal Nehru Technological University
FAQ

Frequently asked questions about Nikhita Medi

Quick answers generated from the profile data available on this page.

What company does Nikhita Medi work for?

Nikhita Medi works for Dentsply Sirona.

What is Nikhita Medi's role at Dentsply Sirona?

Nikhita Medi is listed as Regulatory Affairs Manager at Dentsply Sirona at Dentsply Sirona.

Where is Nikhita Medi based?

Nikhita Medi is based in New York, New York, United States while working with Dentsply Sirona.

What companies has Nikhita Medi worked for?

Nikhita Medi has worked for Dentsply Sirona, Bovie Medical Corporation, Zimmer Biomet, The Harvard Clinical And Translational Center, and Blumea Therapeutics Pvt. Ltd..

Who are Nikhita Medi's colleagues at Dentsply Sirona?

Nikhita Medi's colleagues at Dentsply Sirona include Ruiz Teresa, Michiel Fraikin, Martina Räbiger, Helene Aleros, and Yamen Chaban.

How can I contact Nikhita Medi?

You can use AeroLeads to view verified contact signals for Nikhita Medi at Dentsply Sirona, including work email, phone, and LinkedIn data when available.

What schools did Nikhita Medi attend?

Nikhita Medi holds Master’S Degree, Regulatory Affairs For Drugs Biologics And Medical Devices from Northeastern University.

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