
Aliva Das
Experienced and highly motivated Regulatory Affairs Professional with five years of experience within medical device and pharmaceutical industries.... | Frisco, Texas, United States
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Aliva Das’s Emails al****@me****.com
Aliva Das’s Phone Numbers No phone number available.
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Aliva Das’s Location Frisco, Texas, United States
Aliva Das’s Expertise Experienced and highly motivated Regulatory Affairs Professional with five years of experience within medical device and pharmaceutical industries. Expertise authoring 510(k) application submissions for domestic and international markets and maintaining new/amended license submissions (Health Canada) for Class II devices, EU Medical Device Directive( MDD) and Medical Device Regulation (MDR). Detail-oriented team player capable of directing multiple projects efficiently. Excel in fast-paced, deadline-driven, and matrixed environments. Hold a Regulatory Affairs Certificate and a Quality Assurance Management Certificate in Medical Devices. Core competencies include: EU MDD I EU MDR I Device Registrations Export Certificates Regulatory Applications & Strategies Product Release Process Quality Management Systems (QMS) Quality System Regulations (21 CFR 820) External Audits cGMP GDP Marketing Authorization Licensing for Australia, India, Colombia, & Mexico US FDA Regulations Knowledge Sharing
Aliva Das’s Current Industry Medtronic
Aliva
Das’s Prior Industry
Allergan
|
Regulatory Doctor
|
Glidewell Dental
|
Namsa
|
Beckman Coulter Diagnostics
|
Medtronic
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Work Experience

Medtronic
Sr. Regulatory Affairs Specialist
Mon Mar 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Beckman Coulter Diagnostics
Sr. Regulatory Affairs Specialist
Wed Jan 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Namsa
Regulatory Consultant
Sun Apr 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri May 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Glidewell Dental
Regulatory Affairs Specialist
Fri Jan 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Glidewell Dental
Regulatory Affairs Associate
Thu Jan 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Regulatory Doctor
Intern in Regulatory Affairs
Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Allergan
Quality Professional
Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)