Fiscal Year

2021

Case Number

A-21113-77702

Case Status

Certified

Received Date

2021-04-27

Decision Date

2021-08-24

Refile

N

Original File Date

2021-01-01 10:04:23

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ABBOTT LABORATORIES

Employer Name Slug

abbott-laboratories

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

(224) 667-8130

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

Dept. 32RC, Bldg. AP6A

Employer Contact Address 2

100 Abbott Park Road

Employer Contact City

Abbott Park

Employer Contact State/Province

ILLINOIS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60064-3500

Employer Contact Phone

(224) 667-8130

Employer Contact Email

kathleen.ellwanger@abbott.com

Agent Attorney Name

Keith P Liston

Agent Attorney Firm Name

Hussain Bendersky Liston LLC

Agent Attorney Phone

3124649330

Agent Attorney Address 1

350 North Clark Street

Agent Attorney Address 2

Suite 600

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

P10020253812062

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

77376.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-02-12

PW Expiration Date

2021-06-30

Wage Offer From

135000.00

Wage Offer To

145000.00

Average Salary

140000.00

Wage Unit of Pay

Year

Worksite Address 1

4551 Great America Parkway

Worksite Address 2

Worksite City

Santa Clara

Worksite City Slug

santa-clara

Worksite State

CALIFORNIA

Worksite Postal Code

95054

Job Title

Project Manager, Regulatory Affairs

Job Title Slug

project-manager-regulatory-affairs

Minimum Education

Master's

Major Field of Study

Pharmacy

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Pharmacology, BioMicrobio, Med Tech, Regulatory Affairs or rltd. 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

Regulatory Affairs Specialist or related position.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Masters or foreign equivalent degree in a Pharmacy, Pharmacology, BiologyMicrobiology, Medical Technology, Regulatory Affairs, or in a related field of study Will accept a Bachelors degree in the above fields 5 years of related progressive experience in lieu of a Masters degree each alternative requirement with at least 1 year of experience in i utilizing knowledge and experience in pharmaceutical andor medical device industries to prepare and submit 510k and international product registrations and licensing applications for Class II medical devices, including original submissions and subsequent product enhancements; ii understanding, investigating and evaluating regulatory historybackground of class, disease therapeuticdiagnostic context in order to assess regulatory implications for approval, and determine trade issues to anticipate regulatory obstacles; iii providing regulatory representation and support for design review, design change, and design transfer through product lifecycle; and iv ISO134852016, FDA 21 CFR 820, CLIA, EU IVDD, and Notified BodiesCE Technical Files. 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

2021-02-12

SWA Job Order End Date

2021-03-15

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2021-02-21

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-02-28

Employer Website From Date

2021-01-01 10:04:23

Employer Website To Date

2021-01-01 10:04:23

Professional Organization Ad From Date

2021-01-01 10:04:23

Professional Organization Advertisement To Date

2021-01-01 10:04:23

Job Search Website From Date

2021-02-17

Job Search Website To Date

2021-03-03

Employee Referral Program From Date

2021-03-09

Employee Referral Program To Date

2021-03-23

Local Ethnic Paper From Date

2021-02-24

Local Ethnic Paper To Date

2021-03-02

Radio/TV Ad From Date

2021-01-01 10:04:23

Radio/TV Ad To Date

2021-01-01 10:04:23

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