Fiscal Year

2023

Case Number

A-22038-08480

Case Status

Certified

Received Date

2022-02-15

Decision Date

2022-10-21

Refile

N

Original File Date

2023-01-01 18:17:02

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

2246678130

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

Hussain Bendersky 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

P10021161387096

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

76773.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-11-17

PW Expiration Date

2022-06-30

Wage Offer From

97800.00

Wage Offer To

117300.00

Average Salary

107550.00

Wage Unit of Pay

Year

Worksite Address 1

3200 Lakeside Drive

Worksite Address 2

Worksite City

Santa Clara

Worksite City Slug

santa-clara

Worksite State

CALIFORNIA

Worksite Postal Code

95054

Job Title

Senior Regulatory Affairs Specialist

Job Title Slug

senior-regulatory-affairs-specialist

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 EngMed Devices, BiochemImmunobio, Reg AffairsSci, or rltd flds. 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

Professional Quality Engineering or Regulatory Affairs

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Bachelors or foreign equivalent degree in a PharmacyPharmacology, Biomedical EngineeringMedical Devices, BiochemistryImmunobiology, Regulatory AffairsScience or in a closely related regulatory affairs, quality, or biological science field with at least 3 years of professional quality engineering or regulatory affairs experience. In addition, the position requires at least 1 year of experience in i ensuring and coordinating compliance with quality management system regulatory requirements for medical devices throughout product lifecycle, including ISO 13485, Directive 9342EEC, Directive 9879EC and equivalent local regulations for medical devices and invitro diagnostic IVD medical devices; ii supporting Class II or higher medical device registration product lifecycle, including design, design transfer, manufacturing, corrective and preventive actions CAPA, labeling, complaints, sales, supplier controls, invoicing, maintenance, management responsibility, adverse event reporting and change management; iii providing regulatory representation and support for quality management system and product lifecycle change management; iv preparing, submitting, and maintaining domestic and international technical files, product registrations and licensing applications for Class II or higher medical devices; and v 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.

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

2021-12-07

SWA Job Order End Date

2022-01-06

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2021-12-12

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-12-19

Employer Website From Date

2023-01-01 18:17:02

Employer Website To Date

2023-01-01 18:17:02

Professional Organization Ad From Date

2023-01-01 18:17:02

Professional Organization Advertisement To Date

2023-01-01 18:17:02

Job Search Website From Date

2021-12-09

Job Search Website To Date

2021-12-23

Employee Referral Program From Date

2021-12-08

Employee Referral Program To Date

2021-12-22

Local Ethnic Paper From Date

2021-12-15

Local Ethnic Paper To Date

2021-12-21

Radio/TV Ad From Date

2023-01-01 18:17:02

Radio/TV Ad To Date

2023-01-01 18:17:02

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

AUSTRALIA

Foreign Worker Birth Country

AUSTRALIA

Class of Admission

E-3

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

BIOCHEMISTRY IMMUNOBIOLOGY

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

THE UNIVERSITY OF SYDNEY

Foreign Worker Education Institution Address 1

CITY ROAD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CAMPERDOWNDARLINGTON

Foreign Worker Education Institution State/Province

NEW SOUTH WALES

Foreign Worker Education Institution Country

AUSTRALIA

Foreign Worker Education Institution Postal Code

2006

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