Fiscal Year

2021

Case Number

A-20239-92196

Case Status

Certified

Received Date

2020-09-11

Decision Date

2021-04-27

Refile

N

Original File Date

2021-01-01 09:16:59

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.

Employer Name Slug

st-jude-medical-cardiology-division-inc

Employer Address 1

ONE LILLEHEI PLAZA

Employer Address 2

Employer City

ST. PAUL

Employer City Slug

st-paul

Employer State

MINNESOTA

Employer State Slug

minnesota

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

55117

Employer Phone

651-756-4470

Employer Number of Employees

99000

Employer Year Commenced Business

2006

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Kathleen Ellwanger

Employer Contact Address 1

100 Abbott Park Rd.

Employer Contact Address 2

Employer Contact City

Abbott Park

Employer Contact State/Province

ILLINOIS IL

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60064

Employer Contact Phone

2246678130

Employer Contact Email

kathleen.ellwanger@abbott.com

Agent Attorney Name

Keith P Liston

Agent Attorney Firm Name

Hussain Bendersky Liston LLC

Agent Attorney Phone

3124649362

Agent Attorney Address 1

350 N. Clark Street

Agent Attorney Address 2

Suite 600

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60654

Agent Attorney Email

kliston@hebf.com

PW Track Number

P10020119525193

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

67038.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-08-13

PW Expiration Date

2021-06-30

Wage Offer From

108650.00

Wage Offer To

0.00

Average Salary

108650.00

Wage Unit of Pay

Year

Worksite Address 1

15900 Valley View Court

Worksite Address 2

Worksite City

Sylmar

Worksite City Slug

sylmar

Worksite State

CALIFORNIA

Worksite Postal Code

91342

Job Title

Senior Regulatory Affairs Specialist

Job Title Slug

senior-regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Pharmacy

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biomed Eng, Microbio, Biotech, Life Sci, Reg AffairsScience. See H.14.

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

0

Accept Alternative Job Title

PostDoctoral ScholarResearch Associate, Associate Intern, or related positions.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Masters or foreign equivalent degree in a Pharmacy, Biomedical Engineering, Microbiology, Biotechnology, Life Sciences, Regulatory AffairsScience or in a closely related concentration Will accept a Bachelors degree in the above fields 5 years of related progressive experience in lieu of a Masters degree each alternative requirement with an academic or industrial background in i Preparing and submitting international product registrations and licensing applications multiple risk class products globally; ii ensuring compliance with FDA and international regulatory requirements, including 21 CFR 820 and ISO13485; iii understanding, investigating and evaluating regulatory historybackground of class, disease therapeuticdiagnostic context in order to assess regulatory implications for approval, and determine trade issues to anticipate regulatory obstacles; and iv providing regulatory representation and support for design review, design change and design transfer throughout the product lifecycle. Employer will accept any suitable combination of education, training, or experience.

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

2020-06-08

SWA Job Order End Date

2020-07-10

Sunday Edition Newspaper

Y

First Newspaper Name

Los Angeles Daily News

First Advertisement Start Date

2020-06-14

Second Newspaper Ad Name

Los Angeles Daily News

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-06-21

Employer Website From Date

2021-01-01 09:16:59

Employer Website To Date

2021-01-01 09:16:59

Professional Organization Ad From Date

2021-01-01 09:16:59

Professional Organization Advertisement To Date

2021-01-01 09:16:59

Job Search Website From Date

2020-06-11

Job Search Website To Date

2020-06-25

Employee Referral Program From Date

2020-07-29

Employee Referral Program To Date

2020-08-12

Local Ethnic Paper From Date

2020-06-16

Local Ethnic Paper To Date

2020-06-17

Radio/TV Ad From Date

2021-01-01 09:16:59

Radio/TV Ad To Date

2021-01-01 09:16:59

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

Doctorate

Foreign Worker Information: Major

INTEGRATED LIFE SCIENCES

Foreign Worker Years of Education Completed

2011

Foreign Worker Institution of Education

VIRGINIA COMMONWEALTH UNIVERSITY

Foreign Worker Education Institution Address 1

907 FLOYD AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

RICHMOND

Foreign Worker Education Institution State/Province

VA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

23284

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Keith P Liston

Preparer Title

Partner

Preparer Email

kliston@hebf.com

Employer Information Declaration Name

Kathleen Ellwanger

Employer Information Declaration Title

Senior Paralegal