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Case Number: A-22313-54777
Fiscal year: 2024
Fiscal Year
2024
Case Number
A-22313-54777
Case Status
Certified-Expired
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