Fiscal Year

2022

Case Number

A-21313-70440

Case Status

Certified

Received Date

2021-11-22

Decision Date

2022-06-01

Refile

N

Original File Date

2022-01-01 11:34:06

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Abbott Cardiovascular Systems, Inc.

Employer Name Slug

abbott-cardiovascular-systems-inc

Employer Address 1

An Abbott Laboratories Company

Employer Address 2

100 Abbott Park Road

Employer City

Abbott Park

Employer City Slug

abbott-park

Employer State

ILLINOIS

Employer State Slug

illinois

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

60064

Employer Phone

8479378730

Employer Number of Employees

107000

Employer Year Commenced Business

1888

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Kathleen Ellwanger

Employer Contact Address 1

100 Abbott Park Road

Employer Contact Address 2

Employer Contact City

Abbott Park

Employer Contact State/Province

ILLINOIS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60064

Employer Contact Phone

8479378730

Employer Contact Email

kathleen.ellwanger@abbott.com

Agent Attorney Name

Keith P Liston

Agent Attorney Firm Name

Hussian Bendersky Liston LLC

Agent Attorney Phone

3124649330

Agent Attorney Address 1

1101 West Fulton Market

Agent Attorney Address 2

3rd Floor

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

P10021074146209

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

71864.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-08-12

PW Expiration Date

2022-06-30

Wage Offer From

90000.00

Wage Offer To

110000.00

Average Salary

100000.00

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

Senior Regulatory Affairs Specialist

Job Title Slug

senior-regulatory-affairs-specialist

Minimum Education

Master'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

Med Devices, PharmaPharmaco, Regulatory AffairsSci or rtld regulatoryeng sci fld. 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

12

Accept Alternative Job Title

Project Manager, Technical Manager, Regulatory Affairs Specialist, or related positions.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Masters or foreign equivalent degree in BiomedicalMechanical Engineering, Medical Devices, PharmacyPharmacology, Regulatory AffairsSciences, or in a closely related regulatoryengineering sciences field of study Will accept a Bachelors degree 5 years of progressive professional experience in lieu of a Masters degree each alternative requirement with at least 1 year of experience in i regulatory input and project management to medical device 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 ensure regulatory compliance for medical devices pursuant to EU MDR, FDA 21 CFR Parts 801 820, GMP, ISO13485, and international regulatory requirements; iii maintaining product dossiers and EU technical files; iv preparing and submitting PMA, 510k, IDE, and engineering change orders; and v assessing regulatory implications for device changes, determining trade issues to anticipate regulatory obstacles, and supporting design review, design change and design transfer through 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

2021-08-19

SWA Job Order End Date

2021-09-20

Sunday Edition Newspaper

Y

First Newspaper Name

The Minneapolis StarTribune

First Advertisement Start Date

2021-08-22

Second Newspaper Ad Name

The Minneapolis StarTribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-29

Employer Website From Date

2022-01-01 11:34:06

Employer Website To Date

2022-01-01 11:34:06

Professional Organization Ad From Date

2022-01-01 11:34:06

Professional Organization Advertisement To Date

2022-01-01 11:34:06

Job Search Website From Date

2021-09-14

Job Search Website To Date

2021-09-28

Employee Referral Program From Date

2021-09-13

Employee Referral Program To Date

2021-09-27

Local Ethnic Paper From Date

2021-08-25

Local Ethnic Paper To Date

2021-08-31

Radio/TV Ad From Date

2022-01-01 11:34:06

Radio/TV Ad To Date

2022-01-01 11:34:06

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

Bachelor's

Foreign Worker Information: Major

MECHANICAL ENGINEERING

Foreign Worker Years of Education Completed

2010

Foreign Worker Institution of Education

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY

Foreign Worker Education Institution Address 1

ASHOK NAGAR, KUKATPALLY HOUSING BOARD COLONY, KUKATPALLY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

HYDERABAD

Foreign Worker Education Institution State/Province

TELANGANA

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

500085

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