Fiscal Year

2021

Case Number

A-20118-47758

Case Status

Certified-Expired

Received Date

2020-05-15

Decision Date

2020-10-23

Refile

N

Original File Date

2021-01-01 08:47:40

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

APPLIED MEDICAL RESOURCES CORPORATION

Employer Name Slug

applied-medical-resources-corporation

Employer Address 1

22872 AVENIDA EMPRESA

Employer Address 2

Employer City

RANCHO SANTA MARGARITA

Employer City Slug

rancho-santa-margarita

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92688

Employer Phone

949-713-8000

Employer Number of Employees

3982

Employer Year Commenced Business

1987

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Samir Tall

Employer Contact Address 1

Applied Medical Resources Corporation

Employer Contact Address 2

22872 Avenida Empressa

Employer Contact City

Rancho Santa Margarita

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92688

Employer Contact Phone

949-713-8470

Employer Contact Email

sdando@appliedmedical.com

Agent Attorney Name

Shafiqa B Kureshi

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen and Loewy LLP

Agent Attorney Phone

9492610209

Agent Attorney Address 1

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Address 2

18401 Von Karman Avenue, #255

Agent Attorney City

Irvine

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92612

Agent Attorney Email

skureshi@fragomen.com

PW Track Number

P10019336175361

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

97282.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-03-20

PW Expiration Date

2020-06-30

Wage Offer From

97282.00

Wage Offer To

0.00

Average Salary

97282.00

Wage Unit of Pay

Year

Worksite Address 1

29977 Avenida de las Banderas

Worksite Address 2

Worksite City

Rancho Santa Margarita

Worksite City Slug

rancho-santa-margarita

Worksite State

CALIFORNIA

Worksite Postal Code

92688

Job Title

Regulatory Affairs Specialist III

Job Title Slug

regulatory-affairs-specialist-iii

Minimum Education

Bachelor's

Major Field of Study

Engineering, Medical Device and Diagnostic Engineering*

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H14 for complete list

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

In job offered or closely related occupation.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Bachelors degree or foreign equivalent in Engineering, Medical Device and Diagnostic Engineering, Biotechnology, Biological Sciences, or in a closely related field, plus 5 years of work experience in job offered or in a closely related occupation.br br Special Skills or Requirementsbr 5 years experience in Regulatory Affairs or Quality Assurance in the medical device industry.br 1year experience applying design controls.br Must possess knowledge of required documentation for the introduction of medical devices into various countries and economic regions as required by the respective countries or economic regions health authority.br Experience with performing Internal Quality Audits to ensure the Quality System is in compliance with established requirements and to monitor its effectiveness.br Knowledge of application requirements for Certificate to Foreign Government CFG and Certificate of Exportability.br Experience with initiating, implementing and verifying Corrective and Preventive Actions CAPA to reduce nonconformities.br Write and review protocols, work instructions and other documents for manufacturing and assembly processes.br Root cause analysis and implementation of corrective action for nonconforming reports NCR generated from production processes.br br Must possess expertise knowledge sufficient to adequately perform the duties of the job being offered. Expertise knowledge may be gained through employment experience or education. Such expertise knowledge cannot be quot;quantifiedquot; by quot;time.quot;

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

2020-01-22

SWA Job Order End Date

2020-02-25

Sunday Edition Newspaper

Y

First Newspaper Name

Los Angeles Times, East Zone edition

First Advertisement Start Date

2020-01-26

Second Newspaper Ad Name

Los Angeles Times, East Zone edition

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-02-02

Employer Website From Date

2021-01-01 08:47:40

Employer Website To Date

2021-01-01 08:47:40

Professional Organization Ad From Date

2021-01-01 08:47:40

Professional Organization Advertisement To Date

2021-01-01 08:47:40

Job Search Website From Date

2020-01-29

Job Search Website To Date

2020-02-04

Employee Referral Program From Date

2021-01-01 08:47:40

Employee Referral Program To Date

2021-01-01 08:47:40

Local Ethnic Paper From Date

2020-01-29

Local Ethnic Paper To Date

2020-01-29

Radio/TV Ad From Date

2021-01-01 08:47:40

Radio/TV Ad To Date

2021-01-01 08:47:40

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

MEDICAL DEVICE AND DIAGNOSTIC ENGINEERING

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

3601 TROUSDALE PARKWAY

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

90089-0912

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Shafiqa B Kureshi

Preparer Title

Associate

Preparer Email

skureshi@fragomen.com

Employer Information Declaration Name

Samir Tall

Employer Information Declaration Title

CFO