Manisha Shah is a qualified expert, who works in Celonova Biosciences, Inc main office of which is in 1964. on the position of Product Manager, Regulatory Affairs since 2019. Manisha Shah has earned professional experience in more than seven positions at different companies. Manisha Shah went to the New Jersey City University and was studying there from 2004 to 2009. Carlsbad, California is the city, where this person was lastly known to live. Their email address and phone can be easily accessed through this website by request.
Name variants:
Manisha Shah
Last updated Jun 04, 2024
Contact Information
Last Update
Jun 22, 2022
Email
ms**@celonova.com
Location
Carlsbad, CA
Company
Celonova Biosciences, Inc.
Workplace
Product Manager, Regulatory Affairs
Work History
Product Manager, Regulatory Affairs
8023 Vantage Dr SUITE 1500, San Antonio, TX 78230
from Jan 2019
Senior Regulatory Affairs Specialist
8023 Vantage Dr SUITE 1500, San Antonio, TX 78230
Oct 2016 — Dec 2018
Regulatory Affairs Specialist
1100 Campus Rd, Princeton, NJ
May 2016 — Oct 2016
Regulatory Affairs Specialist
2800 Roosevelt St, Carlsbad, CA 92008
Develop/ execute regulatory strategy and plans for international submission and maintenance of approvals /licenses .
Maintain company's Medical Device Listing and Device Establishment regi...
Mar 2015 — May 2016
Regulatory Affairs Specialist
345 east Main St #p/o box 708, Warsaw, IN 46580
Compiles all documents required in product submissions, license renewal and annual registration.
Manage all document preparation and responses to distributors and regulatory authorities.
...
Dec 2014 — Mar 2015
Regulatory and Compliance Coordinator
100 Devilbiss Dr, Somerset, PA 15501
Mar 2013 — Dec 2014
Quality Assurance Inspector
15 Christopher Way, Eatontown, NJ 07724
Physically handle delicate biomedical devices and execute elctropolishing processes for various cardiovascular and self expandable stents.
Analyze issues in the production line and establi...
Feb 2010 — Feb 2013
Education
2004 — 2009
Occupations
Executive
Produce Manager
Production Manager
Skills
Medical Devices
Regulatory Affairs
Standard Operating Procedure
Fda
Quality Assurance
Sop
U.s. Food and Drug Administration
Regulatory Submissions
Regulatory Requirements
Change Control
Iso 13485
Quality Auditing
Product Complaints
Design Control
Employee Training
Risk Management
Root Cause Analysis
Quality Control
R&D
Quality System
Capa
21 Cfr Part 11
Gmp
Laboratory