ABBOTT CARDIOVASCULAR SYSTEMS, INC.

Regulatory Affairs Specialist

A-22222-03918 H-1B 2023 Certified

Salary

$61,298

Visa Type

H-1B

Job Title

Regulatory Affairs Specialist

Employee's Citizenship

INDIA

Graduate School

UNIVERSITY OF SOUTHERN CALIFORNIA

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22222-03918

Case Status Certified

Received Date 2022-08-11

Decision Date 2023-05-12

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 325412

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 8479378730

Employer Contact Email kathleen.ellwanger@abbott.com

Attorney

11 fields

Agent/ Attorney Name Keith P Liston

Agent/ Attorney Firm Name Hussain Bendersky 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 P10021313694541

Prevailing Wage SOC Code 13-1041.07

Prevailing Wage SOC Title Regulatory Affairs Specialists

Prevailing Wage Skill Level Level I

Prevailing Wage 61298

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-05-18

Prevailing Wage Expiration Date 2022-08-16

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 Med Device Eng, PharmaPharmaco, Reg AffairsSci, or rltd fld. 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 24

Accept Alternate Job Title Regulatory Affairs, Regulatory Industry Medical, Pharma or Nutritional, or rltd positions.

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Bachelors or foreign equivalent degree in Biomedical Engineering, Medical Device Engineering, PharmacyPharmacology, Regulatory AffairsSciences, or in related life sciences, medical, or engineering field of study with at least 2 years of regulatory affairs experience or experience within a regulated industry medical, pharmaceutical, or nutritional products. In addition, the position requires an academic or industrial background in i regulatory input and project management to medical device product lifecycle planning, product testing protocols, reports, and product approval regulatory strategies; ii preparing regulatory submissions, maintaining regulatory files for product registrations and product renewals, and ensuring regulatory compliance for medical devices pursuant to EU MDR, FDA 21 CFR Parts 801 820, GMP, ISO13485, and international regulatory requirements; iii preparing and submitting PMA, 510k, IDE, and engineering change orders; iv assessing regulatory implications for device changes, determining trade issues to anticipate regulatory obstacles, and supporting design review, design change and design transfer through product lifecycle; and v understanding, investigating, and evaluating regulatory historybackground of class, diseasetherapeuticdiagnostic context in order to assess regulatory implications for approval.

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 2022-05-27

Job Oder End Date 2022-06-27

Sunday Edition Newspaper Y

First Newspaper Name San Francisco Chronicle

First Advertisement Start Date 2022-06-05

Second Newspaper Name San Francisco Chronicle

Second Advertisement Type Newspaper

Second Ad Start Date 2022-06-12

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 2022-06-20

Job Search Website to Date 2022-07-05

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date 2022-06-16

Employee Referral Program to Date 2022-06-30

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-06-08

Local Ethnic Newspaper to Date 2022-06-14

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 INDIA

Foreign Worker Birth Country INDIA

Class of Admission H-1B

Employee Info

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major MEDICAL DEVICE AND DIAGNOSTIC ENGINEERING

Year of Compelted Education 2018

Foreign Worker Istitution of Eduation UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Instution Address Line 1 OFFICE OF INTERNATIONAL STUDENT SERVICES

Foreign Worker Education Institution Address Line 2 300 STUDENT UNION

Foreign Worker Education Institution City LOS ANGELES

Foreign Worker Educatution Institution State CA

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 90089

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 Partner

Preparer Email kliston@hebf.com

Employer Information Declaration Name Kathleen Ellwanger

Employer Declaration Title Senior Paralegal