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Case Number: A-20302-14086

Fiscal year: 2022

Fiscal Year

2022

Case Number

A-20302-14086

Case Status

Certified-Expired

Received Date

2020-11-12

Decision Date

2021-10-08

Refile

N

Original File Date

2022-01-01 10:15:33

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Reflexion Medical Inc

Employer Name Slug

reflexion-medical-inc

Employer Address 1

25841 Industrial Blvd, Suite 275

Employer Address 2

Employer City

Hayward

Employer City Slug

hayward

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

94545

Employer Phone

6502399070

Employer Number of Employees

184

Employer Year Commenced Business

2009

NAICS Code

334517

FW Ownership Interest

N

Employer Contact Name

Laurie Moncrief

Employer Contact Address 1

25841 Industrial Blvd, Suite 275

Employer Contact Address 2

Employer Contact City

Hayward

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

94545

Employer Contact Phone

6502399070

Employer Contact Email

hr@reflexion.com

Agent Attorney Name

James G Clare

Agent Attorney Firm Name

Law Offices of J. Gregory Clare

Agent Attorney Phone

(502) 451-3030

Agent Attorney Address 1

2933 Bowman Avenue

Agent Attorney Address 2

Agent Attorney City

Louisville

Agent Attorney State/Province

KENTUCKY

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

40205

Agent Attorney Email

greg.clare@jgclare.com

PW Track Number

P10020078417163

PW SOC Code

13-1041

PW SOC Title

Senior Regulatory Affairs Specialist

PW Skill Level

Level IV

PW Wage

107058.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-06-11

PW Expiration Date

2020-09-09

Wage Offer From

170000.00

Wage Offer To

0.00

Average Salary

170000.00

Wage Unit of Pay

Year

Worksite Address 1

25841 Industrial Boulevard

Worksite Address 2

Suite 275

Worksite City

Hayward

Worksite City Slug

hayward

Worksite State

CALIFORNIA

Worksite Postal Code

94545

Job Title

Senior Regulatory Affairs Specialist

Job Title Slug

senior-regulatory-affairs-specialist

Minimum Education

Bachelor's

Major Field of Study

Scientific discipline (Enginnering,Biomedical,Medicine,Pharmacy,Physics,Biology)

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

N

Accept Alternative Occupation Months

Accept Alternative Job Title

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

60 months experience in medical device regulatory affairs. Current Regulatory Affairs Certification RAC from the Regulatory Affairs Professionals Society RAPS. The 60 months experience in medical device regulatory affairs must be for devices that are electromechanical or complex softwaredriven medical devices. Experience cannot be exclusively IVD devices.br br The 60 months experience must includebr br The development, writing and submittal of at least one successful 510KPMADe Novo U.S. submissionbr br At least one submission for each of U.S. 510K; Health Canada medical device license application; and CE Mark application technical filebr br Working knowledge of ISO 13485, IEC 60601, IEC 62304, IEC 62366, ISO 14971 as evidenced by coursework or at least one submission that required use of each standardbr br Knowledge of software development as it relates to regulatory submissions as evidenced by at least one submission that included software subject to IEC 62304br br Experience working on post market activities such as establishment licenses and registrationsbr br Leading regulatory review of complaints for MDR reporting decisions and submitting reports to FDA

Combination Occupation

N

Offered to Applicant Foreign Worker

Y

Foreign Worker Live on Premises

N

Foreign Worker Live in Domestic Service

N

Foreign Worker Live in Domestic Service Count

Professional Occupation

Y

Application for College/University Teacher

N

SWA Job Order Start Date

2020-06-26

SWA Job Order End Date

2020-07-31

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2020-07-05

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-07-12

Employer Website From Date

2020-06-26

Employer Website To Date

2020-07-30

Professional Organization Ad From Date

2022-01-01 10:15:33

Professional Organization Advertisement To Date

2022-01-01 10:15:33

Job Search Website From Date

2020-06-30

Job Search Website To Date

2020-07-28

Employee Referral Program From Date

2022-01-01 10:15:33

Employee Referral Program To Date

2022-01-01 10:15:33

Local Ethnic Paper From Date

2022-01-01 10:15:33

Local Ethnic Paper To Date

2022-01-01 10:15:33

Radio/TV Ad From Date

2022-01-01 10:15:33

Radio/TV Ad To Date

2022-01-01 10:15:33

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

REGULATORY SCIENCE

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

1540 ALCAZAR STREET

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LOS ANGELES

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

90089

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

James G Clare

Preparer Title

Attorney

Preparer Email

greg.clare@jgclare.com

Employer Information Declaration Name

Laurie H Moncrief

Employer Information Declaration Title

Director of Human Resources