Fiscal Year

2021

Case Number

A-21160-98537

Case Status

Withdrawn

Received Date

2021-07-21

Decision Date

2021-08-19

Refile

N

Original File Date

2021-01-01 10:02:52

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

P10020318912364

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

76086.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-03-31

PW Expiration Date

2021-06-30

Wage Offer From

135000.00

Wage Offer To

150000.00

Average Salary

142500.00

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

Manager, Regulatory Affairs, US

Job Title Slug

manager-regulatory-affairs-us

Minimum Education

Master'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, Regulatory Affairs or rltd conc. Emp will accept any combo edu, trng, or exp. 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

24

Accept Alternative Job Title

Regulatory Affairs Specialist or related positions.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Masters or foreign equivalent degree in a Pharmacy, Pharmacology, Biomedical Engineering, Regulatory Affairs, or in a closely related concentration Will accept a Bachelors degree in the above fields plus five years of related progressive experience in lieu of a Masters degree each alternative requirement with at least 2 years of experience in i people management, mentoring junior employees, or leading cross functional teams and acting as a company representative in direct communications with US FDA and other global regulatory agencies; ii reviewing and approving product specifications and associated design verification testing; iii reviewing and approving manufacturing process validations, performing regulatory impact assessments of manufacturing changes, and performing onmarket change management activities to prepare and submit US 510k Class II documentation or US Class III PMAs including annual reports and supplements for medical devices original submissions and subsequent product enhancements for manufacturing process changes; iv understanding, investigating and evaluating regulatory historybackground of class, disease therapeuticdiagnostic context to assess regulatory implications for approval; v providing regulatory representation and support for design review, design change and design transfer throughout the product lifecycle; and vi maintaining the effectiveness of the Quality Management System QMS pursuant to 21 CFR 820 and ISO13485. 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

2021-03-16

SWA Job Order End Date

2021-04-15

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2021-03-21

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-03-28

Employer Website From Date

2021-01-01 10:02:52

Employer Website To Date

2021-01-01 10:02:52

Professional Organization Ad From Date

2021-01-01 10:02:52

Professional Organization Advertisement To Date

2021-01-01 10:02:52

Job Search Website From Date

2021-03-24

Job Search Website To Date

2021-04-07

Employee Referral Program From Date

2021-07-07

Employee Referral Program To Date

2021-07-21

Local Ethnic Paper From Date

2021-03-25

Local Ethnic Paper To Date

2021-03-31

Radio/TV Ad From Date

2021-01-01 10:02:52

Radio/TV Ad To Date

2021-01-01 10:02:52

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

2011

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