All Details of Green Card Application:
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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