Fiscal Year

2024

Case Number

A-22284-37444

Case Status

Certified-Expired

Received Date

2022-11-10

Decision Date

2023-10-04

Refile

N

Original File Date

2024-01-01 00:01:34

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

P10022045900718

PW SOC Code

11-9199.01

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level II

PW Wage

109200.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-08-17

PW Expiration Date

2023-06-30

Wage Offer From

110000.00

Wage Offer To

125000.00

Average Salary

117500.00

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 Manager

Job Title Slug

regulatory-affairs-manager

Minimum Education

Master's

Major Field of Study

Regulatory Affairs/Science

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

24

Accept Alternative Job Title

Regulatory Affairs Specialist, Sr. Regulatory Affairs Specialist,or related

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Masters or foreign equivalent degree in Regulatory AffairsScience, PharmacyPharmacology, Medical Technology, Biomedical Engineering, Biology, Chemistry, Microbiology, or in a closely related regulatory affairs or healthmedical sciences field with at least 2 years of experience in i monitoring and navigating evolving regulatory requirements for Class III medical device manufacturing, design, labeling, quality system changes, and regulatory submission strategies; ii executing preapproval compliance activities for FDA, EU and various regulatory agencies, including LetterToFile, Periodic Reports, Supplements, Technical Files, Design Dossiers, and Change Notifications, and maintenance of Device Registrations and Certificate Renewals; iii reviewing and approving advertising and promotional items to ensure regulatory compliance with post marketing approval requirements; iv providing audit support using knowledge of Quality System Regulation QSR 21 CFR 820, EU Medical Device Directive EU MDD 9342EEC, EU Medical Device Regulation EU MDR 2017745, Canadian Medical Device Regulation CMDR, Australia medical device regulations ARTG, Japan regulations and current ISO 13485 requirements; v communicating with regulatory agencies during submission review process; and vi working on multiple competing priorities and mentoring and training regulatory affairs professionals.

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

2022-08-17

SWA Job Order End Date

2022-09-16

Sunday Edition Newspaper

Y

First Newspaper Name

Star Tribune

First Advertisement Start Date

2022-09-11

Second Newspaper Ad Name

Star Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-09-18

Employer Website From Date

2024-01-01 00:01:34

Employer Website To Date

2024-01-01 00:01:34

Professional Organization Ad From Date

2024-01-01 00:01:34

Professional Organization Advertisement To Date

2024-01-01 00:01:34

Job Search Website From Date

2022-09-08

Job Search Website To Date

2022-09-22

Employee Referral Program From Date

2022-09-22

Employee Referral Program To Date

2022-10-06

Local Ethnic Paper From Date

2022-09-14

Local Ethnic Paper To Date

2022-09-20

Radio/TV Ad From Date

2024-01-01 00:01:34

Radio/TV Ad To Date

2024-01-01 00:01:34

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 AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2012

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

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