Jason Smith Email & Phone Number | I've written over fifteen 510(k) submissions for class II medical devices, and over fifteen PMA supplements (all types) for class III medical devices. I've also written technical files and design dossiers (Europe), as well as prepared regulatory submissions for Canada and Australia. I am actively involved in preparation for the European Medical Device Regulations. I've participated in design teams, in all phases, to ensure that all regulatory deliverables are achieved. I've reviewed and approved design testing, design validation, process validation, and change orders. I've also reviewed review advertising to ensure its truthfulness and accuracy. Specialties: 510(k) submissions, CE mark technical files, CE Mark class III design dossiers, PMAs, PMA Supplements, European MDR

Jason Smith

I've written over fifteen 510(k) submissions for class II medical devices, and over fifteen PMA supp...
Irvine, California, United States

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Jason Smith’s Location Irvine, California, United States

Jason Smith’s Current Industry Abbvie

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Associate Director - Medical Devices and Combination Products

2021-06-01 00:00:00 - Present

Senior Manager Regulatory Affairs - Device/Combination Products

2019-04-01 00:00:00 - 2021-06-01 00:00:00

Regulatory Affairs Project Manager

2016-11-01 00:00:00 - 2019-03-01 00:00:00

Regulatory Affairs Manager

2011-09-01 00:00:00 - 2016-11-01 00:00:00

Consultant

2011-01-01 00:00:00 - 2011-01-01 00:00:00

Regulatory Affairs Manager

1998-02-01 00:00:00 - 2010-06-01 00:00:00

Regulatory Affairs Coordinator

1994-04-01 00:00:00 - 1998-02-01 00:00:00

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Jason Smith is a I've written over fifteen 510(k) submissions for class II medical devices, and over fifteen PMA supplements (all types) for class III medical devices. I've also written technical files and design dossiers (Europe), as well as prepared regulatory submissions for Canada and Australia. I am actively involved in preparation for the European Medical Device Regulations. I've participated in design teams, in all phases, to ensure that all regulatory deliverables are achieved. I've reviewed and approved design testing, design validation, process validation, and change orders. I've also reviewed review advertising to ensure its truthfulness and accuracy. Specialties: 510(k) submissions, CE mark technical files, CE Mark class III design dossiers, PMAs, PMA Supplements, European MDR

Jason Smith has prior
experience in the following industries:
Allergan | Johnson And Johnson Vision | Bausch Lomb | Masimo | Edwards Lifesciences | 3m

Jason Smith has the following professional experience:
Abbvie | Allergan | Johnson And Johnson Vision | Bausch Lomb | Masimo | Edwards Lifesciences | 3m