Rac Leena Kadakia Email & Phone Number | • Dedicated medical device professional with strong experience in project management, design controls, design verification and validation, risk management, and worldwide regulatory submissions • Product development experience from initial concept to commercialization • Strong experience and familiarity with harmonized standards - such as Risk Management (ISO14971), Quality Systems (ISO 13485, 21CFR820), Biocompatibility (ISO 10993), Sterilization (ISO11135/11137) • Masters of Biomedical Engineering • RAC certified and familiar with the FDA and EU regulatory requirements for medical devices • Strong organization and communication skills with ability to multi-task • Familiar with electrophysiology, cardiovascular & peripheral vascular procedures, dialysis, ultrasound, pulmonary applications, electrical stimulation devices, radiotherapy, software, and wireless data transmission

Rac Leena Kadakia

• Dedicated medical device professional with strong experience in project management, design control...
San Francisco Bay Area, San Francisco Bay Area, United States

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Rac Leena Kadakia’s Email lkadakia@reflexion.com

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Rac Leena Kadakia’s Location San Francisco Bay Area, San Francisco Bay Area, United States

Rac Leena Kadakia’s Current Industry Reflexion Medical

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Work Experience

Reflexion Medical

Vice President of Regulatory Affairs

2022-11-01 00:00:00 - Present

Multiple Companies

Consultant, Regulatory Affairs, Quality, and Engineering

2013-09-01 00:00:00 - 2020-01-01 00:00:00

Hansen Medical

Consultant - Engineering/Design Controls

2012-12-01 00:00:00 - 2013-12-01 00:00:00

Abbott Vascular

Senior R&D Engineer

2012-06-01 00:00:00 - 2012-11-01 00:00:00

Memry

Product Development Engineer

2007-01-01 00:00:00 - 2008-08-01 00:00:00

Cordis

R&D Engineer

2005-09-01 00:00:00 - 2007-01-01 00:00:00

Novellus Systems

Process Dev. Engineer

2000-01-01 00:00:00 - 2003-01-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Rac Leena Kadakia

Rac Leena Kadakia is located at
San Francisco Bay Area, San Francisco Bay Area, United States

Rac Leena Kadakia is a • Dedicated medical device professional with strong experience in project management, design controls, design verification and validation, risk management, and worldwide regulatory submissions • Product development experience from initial concept to commercialization • Strong experience and familiarity with harmonized standards - such as Risk Management (ISO14971), Quality Systems (ISO 13485, 21CFR820), Biocompatibility (ISO 10993), Sterilization (ISO11135/11137) • Masters of Biomedical Engineering • RAC certified and familiar with the FDA and EU regulatory requirements for medical devices • Strong organization and communication skills with ability to multi-task • Familiar with electrophysiology, cardiovascular & peripheral vascular procedures, dialysis, ultrasound, pulmonary applications, electrical stimulation devices, radiotherapy, software, and wireless data transmission

Rac Leena Kadakia currently works in the Reflexion Medical |

No Languages Available

Rac Leena Kadakia has prior
experience in the following industries:
Multiple Companies | Hansen Medical | Abbott Vascular | Memry | Cordis | Novellus Systems

Rac Leena Kadakia has the following professional experience:
Reflexion Medical | Multiple Companies | Hansen Medical | Abbott Vascular | Memry | Cordis | Novellus Systems