ABBOTT CARDIOVASCULAR SYSTEMS, INC.

Regulatory Affairs Specialist

A-23004-82133 H-1B 2023 Withdrawn

Salary

$82,534

Visa Type

H-1B

Job Title

Regulatory Affairs Specialist

Employee's Citizenship

TAIWAN

Graduate School

THE GEORGE WASHINGTON UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-23004-82133

Case Status Withdrawn

Received Date 2023-02-02

Decision Date 2023-06-23

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name ABBOTT CARDIOVASCULAR SYSTEMS, INC.

Employer Address_Line 1 AN ABBOTT LABORATORIES COMPANY

Employer Address_Line 2 100 ABBOTT PARK ROAD

Employer City ABBOTT PARK

State -

Employer State/ Province ILLINOIS

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 60064

Employer Phone No. 2246678130

Employer Phone Extent No. -

Total Number of Employees 113000

Employer Year of Commenced 1888

NAICS Code 32541

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Kathleen Ellwanger

Employer Contact Address Line1 100 Abbott Park Road

Employer Contact Address Line2 -

Employer Contact City Abbott Park

Employer Contact State/ Provice ILLINOIS

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 60064

Employer Contact Phone 2246678130

Employer Contact Email kathleen.ellwanger@abbott.com

Attorney

11 fields

Agent/ Attorney Name Keith P Liston

Agent/ Attorney Firm Name Hussain, Bendersky, and Liston LLC

Agent/ Attorney Phone 3124649330

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 1101 West Fulton Market

Agent/ Attorney Address Line 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

Position Info

89 fields

Prevailing Wage Track Number P10022109084224

Prevailing Wage SOC Code 13-1041.07

Prevailing Wage SOC Title Regulatory Affairs Specialists

Prevailing Wage Skill Level Level II

Prevailing Wage 82534

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-11-01

Prevailing Wage Expiration Date 2023-06-30

Wage Offer From 95000

Wage Offer To 105000

Wage Offer Unit of Pay Year

Workstie Address Line 1 3200 Lakeside Drive

Worksite Address Line 2 -

Worksite City Santa Clara

Worksite State CALIFORNIA

Worksite Postal Code 95054

Job Title Regulatory Affairs Specialist

Minimum Education Bachelor's

Other Degree/ Diploma -

Major Field of Study Biomedical Engineering

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

Accept Alternate Field of Study Y

Accept Alternate Major See H.14.

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 36

Accept Alternate Job Title Medical Product Manager, Regulatory Affairs Associate, or related

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Bachelors or foreign equivalent degree in Biomedical Engineering, PharmacyPharmacology, BiochemistryImmunobiology, Regulatory AffairsScience or in a closely related regulatory affairs, quality, or biological science field with at least 3 years of experience in i ensuring and coordinating compliance with quality management system regulatory requirements for medical devices throughout product lifecycle, including ISO 13485, FDA 21 CFR 820, EU MDD, and equivalent local regulations for medical devices; ii providing regulatory representation and support for quality management system and product lifecycle change management; iii preparing, submitting, and maintaining domestic and international technical files, product registrations and licensing applications for Class II or higher medical devices; and iv understanding, investigating, and evaluating regulatory historybackground of class, disease therapeuticdiagnostic context to assess regulatory implications for approval, and determining trade issues to anticipate regulatory obstacles.

Combination Occupation N

Offered to Applied Foreign Worker Y

ForeignWorker Live on Premises N

Live in Domestic Service Worker N

Employment Contract -

Professional Occupation Y

College/ University Teacher N

Competitive Process -

Basic Recruitment Process -

Teacher Select Date -

Teacher Publish Journal Name -

Additional Recruitment Information -

Job Oder Start Date 2022-11-01

Job Oder End Date 2022-12-01

Sunday Edition Newspaper Y

First Newspaper Name San Francisco Chronicle

First Advertisement Start Date 2022-11-06

Second Newspaper Name San Francisco Chronicle

Second Advertisement Type Newspaper

Second Ad Start Date 2022-11-20

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date -

Employer Website to Date -

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-11-03

Job Search Website to Date 2022-11-18

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date 2022-11-28

Employee Referral Program to Date 2022-12-12

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-11-09

Local Ethnic Newspaper to Date 2022-11-15

Radio/TV Ad from Date -

Radio/TV Ad to Date -

Employer Received the Payment N

Payment Details -

Bargaining Representative Notified N/A

Posted Notice at Worksite Y

Layoff in Past Six Months N

US Worker Considered -

Country of Citizenship TAIWAN

Foreign Worker Birth Country TAIWAN

Class of Admission H-1B

Employee Info

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major BIOMEDICAL ENGINEERING

Year of Compelted Education 2019

Foreign Worker Istitution of Eduation THE GEORGE WASHINGTON UNIVERSITY

Foreign Worker Education Instution Address Line 1 2121 I STREET NW

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City WASHINGTON

Foreign Worker Educatution Institution State DC

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 20052

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N/A

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name Keith P Liston

Preparer Title Attorney

Preparer Email kliston@hebf.com

Employer Information Declaration Name Kathleen Ellwanger

Employer Declaration Title Senior Paralegal