Fiscal Year

2022

Case Number

A-21221-29185

Case Status

Certified-Expired

Received Date

2021-08-13

Decision Date

2022-02-04

Refile

N

Original File Date

2022-01-01 10:53:04

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Abbott Diabetes Care, Inc.

Employer Name Slug

abbott-diabetes-care-inc

Employer Address 1

100 Abbott Park Road

Employer Address 2

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

8479378130

Employer Number of Employees

107000

Employer Year Commenced Business

1996

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Kathleen Ellwanger

Employer Contact Address 1

100 Abbott Park Road

Employer Contact Address 2

Dept 32RC, Bldg AP6A

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

8479378130

Employer Contact Email

kathleen.ellwanger@abbott.com

Agent Attorney Name

Keith P Liston

Agent Attorney Firm Name

Hussain Bendersky Liston LLC

Agent Attorney Phone

8476930673

Agent Attorney Address 1

Hussain Bendersky and Liston LLC

Agent Attorney Address 2

350 North Clark Street

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

P10021025031171

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level III

PW Wage

92955.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-06-07

PW Expiration Date

2021-09-05

Wage Offer From

105000.00

Wage Offer To

115000.00

Average Salary

110000.00

Wage Unit of Pay

Year

Worksite Address 1

1360 South Loop Road

Worksite Address 2

Worksite City

Alameda

Worksite City Slug

alameda

Worksite State

CALIFORNIA

Worksite Postal Code

94502

Job Title

Senior Regulatory Affairs Specialist - EMEA

Job Title Slug

senior-regulatory-affairs-specialist-emea

Minimum Education

Bachelor's

Major Field of Study

Pharmacy/Pharmacology

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, Regulatory AffairsSci, or rltd. 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

36

Accept Alternative Job Title

Regulatory Affairs Specialist, Regulatory Affairs Analyst, or related positions.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Bachelors or foreign equivalent degree in PharmacyPharmacology, Biomedical Engineering, Microbiology, Biotechnology, Life Sciences, Regulatory AffairsScience or in a closely related concentration with at least 3 years of regulatory affairs experience in i preparing and submitting international regulatory submissions for multiple medical devices within multiple risk classes globally; ii ensuring compliance with FDA, EU, or international regulatory requirements, including 21 CFR 820 and ISO13485, and maintaining product dossiers and EU technical files; iii understanding, investigating and evaluating regulatory historybackground of class, disease therapeuticdiagnostic context to assess regulatory implications for approval; iv reviewing change controls related to product and manufacturing changes to determine the level of change and consequent submission requirements; and v providing regulatory representation and support for design review, design change and design transfer throughout the product lifecycle.

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

2021-06-07

SWA Job Order End Date

2021-07-07

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2021-06-13

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-06-20

Employer Website From Date

2022-01-01 10:53:04

Employer Website To Date

2022-01-01 10:53:04

Professional Organization Ad From Date

2022-01-01 10:53:04

Professional Organization Advertisement To Date

2022-01-01 10:53:04

Job Search Website From Date

2021-06-18

Job Search Website To Date

2021-07-07

Employee Referral Program From Date

2021-06-08

Employee Referral Program To Date

2021-06-22

Local Ethnic Paper From Date

2021-06-17

Local Ethnic Paper To Date

2021-06-23

Radio/TV Ad From Date

2022-01-01 10:53:04

Radio/TV Ad To Date

2022-01-01 10:53:04

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

2015

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

Partner

Preparer Email

kliston@hebf.com

Employer Information Declaration Name

Kathleen Ellwanger

Employer Information Declaration Title

Senior Paralegal