Fiscal Year

2024

Case Number

A-22313-54777

Case Status

Certified

Received Date

2022-12-07

Decision Date

2024-01-19

Refile

N

Original File Date

2024-01-01 00:35:39

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

113000

Employer Year Commenced Business

2006

NAICS Code

32541

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, and Liston LLC

Agent Attorney Phone

3124649330

Agent Attorney Address 1

1101 West Fulton Market

Agent Attorney Address 2

Suite 300

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60607

Agent Attorney Email

kliston@hebf.com

PW Track Number

P10022041892803

PW SOC Code

13-1041.07

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level I

PW Wage

56347.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-09-26

PW Expiration Date

2023-06-30

Wage Offer From

80000.00

Wage Offer To

90000.00

Average Salary

85000.00

Wage Unit of Pay

Year

Worksite Address 1

5050 Nathan Lane N.

Worksite Address 2

Worksite City

Plymouth

Worksite City Slug

plymouth

Worksite State

MINNESOTA

Worksite Postal Code

55442

Job Title

Regulatory Affairs Specialist II

Job Title Slug

regulatory-affairs-specialist-ii

Minimum Education

Bachelor's

Major Field of Study

Biomedical/Mechanical Engineering

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.14.

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

0

Accept Alternative Job Title

Academic or industrial background

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Bachelors or foreign equivalent degree in BiomedicalMechanical Engineering, Medical Devices, PharmacyPharmacology, Regulatory AffairsSciences, or in a closely related technical field of study with at least 2 years of professional Regulatory Affairs experience. In addition, the position requires an academic or industrial background in i providing regulatory input and project management to product lifecycle planning, product testing protocols, reports, and product approval regulatory strategies; ii preparing regulatory submissions, maintain regulatory files for product registrations and product renewals, and ensuring regulatory compliance for medical devices pursuant to FDA 21 CFR Parts 801 820, GMP, ISO13485, and international regulatory requirements; iii maintaining EU technical files and design dossiers; iv assessing regulatory implications for product changes and determining trade issues to anticipate regulatory obstacles; and v providing regulatory support to crossfunctional project teams.

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

2022-09-27

SWA Job Order End Date

2022-11-03

Sunday Edition Newspaper

Y

First Newspaper Name

Star Tribune

First Advertisement Start Date

2022-10-02

Second Newspaper Ad Name

Star Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-10-09

Employer Website From Date

2024-01-01 00:35:39

Employer Website To Date

2024-01-01 00:35:39

Professional Organization Ad From Date

2024-01-01 00:35:39

Professional Organization Advertisement To Date

2024-01-01 00:35:39

Job Search Website From Date

2022-09-30

Job Search Website To Date

2022-10-14

Employee Referral Program From Date

2022-09-29

Employee Referral Program To Date

2022-10-13

Local Ethnic Paper From Date

2022-10-05

Local Ethnic Paper To Date

2022-10-11

Radio/TV Ad From Date

2024-01-01 00:35:39

Radio/TV Ad To Date

2024-01-01 00:35:39

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

ECUADOR

Foreign Worker Birth Country

ECUADOR

Class of Admission

H-1B

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

MECHANICAL ENGINEERING

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

SAN FRANCISCO OF QUITO UNIVERSITY

Foreign Worker Education Institution Address 1

CAMPUS CUMBAY, DIEGO DE ROBLES

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

QUITO

Foreign Worker Education Institution State/Province

PICHINCHA

Foreign Worker Education Institution Country

ECUADOR

Foreign Worker Education Institution Postal Code

170901

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

Attorney

Preparer Email

kliston@hebf.com

Employer Information Declaration Name

Kathleen Ellwanger

Employer Information Declaration Title

Senior Paralegal