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Debleena S. | Elance
 
176985602337900
Last Sign-in: May 14, 2014

Debleena S.

Regulatory Affairs
   United States
  |   Agoura Hills, CA

Overview

Minimum Hourly Rate $11

- Regulatory strategy and write-up of 510 (K) FDA submissions for Class I, II, and III devices
- Obtain clearances for medical device submissions including US 510(K), Health Canada Licenses, EU Technical Files, India, China, Japan, and other countries.
? International medical device registration, including obtaining Certificates to Foreign Governments, preparing Declaration of Conformity.
? Correspond with FDA, Notified bodies and other International Consultants.
? Regulatory notifications
- Guidance on domestic and global...

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Skills (5)

Tested
Medical Device
Pharmaceuticals
Medical Writing
Regulatory FDA Submissions
International Regulatory Approvals
Overview  |  Job History  |  Resume/C.V.

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sinhadr
Type
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Member Since
May 2014
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Debleena S. | Elance

Debleena S.