Fiscal Year

2022

Case Number

A-21251-41355

Case Status

Certified-Expired

Received Date

2021-09-16

Decision Date

2022-03-21

Refile

N

Original File Date

2022-01-01 11:07:09

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.

Employer Name Slug

st-jude-medical-cardiology-division-inc

Employer Address 1

ONE LILLEHEI PLAZA

Employer Address 2

Employer City

ST. PAUL

Employer City Slug

st-paul

Employer State

MINNESOTA

Employer State Slug

minnesota

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

55117

Employer Phone

651-756-4470

Employer Number of Employees

107000

Employer Year Commenced Business

2006

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Kathleen Ellwanger

Employer Contact Address 1

100 Abbott Park Rd.

Employer Contact Address 2

Employer Contact City

Abbott Park

Employer Contact State/Province

ILLINOIS IL

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60064

Employer Contact Phone

2246678130

Employer Contact Email

kathleen.ellwanger@abbott.com

Agent Attorney Name

Keith P Liston

Agent Attorney Firm Name

Hussain, Bendersky, and Liston LLC

Agent Attorney Phone

3124649362

Agent Attorney Address 1

350 N. 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

P10021049085291

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level II

PW Wage

136490.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-07-12

PW Expiration Date

2022-06-30

Wage Offer From

145000.00

Wage Offer To

155000.00

Average Salary

150000.00

Wage Unit of Pay

Year

Worksite Address 1

6101 Stoneridge Dr.

Worksite Address 2

Worksite City

Pleasanton

Worksite City Slug

pleasanton

Worksite State

CALIFORNIA

Worksite Postal Code

94588

Job Title

Regulatory Affairs Manager

Job Title Slug

regulatory-affairs-manager

Minimum Education

Master's

Major Field of Study

Regulatory Affairs/Science

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Refer to section 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

Sr. Regulatory Affairs Specialist or related

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Masters or foreign equivalent degree in Regulatory AffairsScience, Pharmacy, Medical Devices, Biomedical Engineering, Biology or in a closely related regulatory affairshealth science field of study Will accept a Bachelors degree 5 years of progressive professional experience in lieu of Masters degree each alternative requirement with at least 2 years of experience in i monitoring and navigating evolving regulatory requirements for Class I, II, and III medical device manufacturing, design, labeling, quality system changes, and regulatory submission strategies ; ii executing preapproval compliance activities for FDA, EU and various regulatory agencies, including 510ks, LetterToFile, Periodic Reports, Supplements, Technical Files, Design Dossiers, and Change Notifications, and maintenance of Device Registrations and Certificate Renewals; iii reviewing and approving advertising and promotional items to ensure regulatory compliance with post marketing approval requirements; iv providing audit support using knowledge of Quality System Regulation QSR 21 CFR 820, EU Medical Device Directive EU MDD 9342EEC, EU Medical Device Regulation EU MDR 2017745, Canadian Medical Device Regulation CMDR, Australia medical device regulations ARTG, JPAL Japan regulations and current ISO 13485 requirements; v using engineering principles of human anatomy in a medical device environment to anticipate regulatory obstacles and emerging issues throughout product life cycle and develop solutions with team members; vi communicating with regulatory agencies during submission review process; and vii working on multiple competing priorities and mentoring, training, and recruiting regulatory affairs professionals. 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

2021-07-14

SWA Job Order End Date

2021-08-16

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2021-07-25

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-01

Employer Website From Date

2022-01-01 11:07:09

Employer Website To Date

2022-01-01 11:07:09

Professional Organization Ad From Date

2022-01-01 11:07:09

Professional Organization Advertisement To Date

2022-01-01 11:07:09

Job Search Website From Date

2021-07-22

Job Search Website To Date

2021-08-05

Employee Referral Program From Date

2021-07-16

Employee Referral Program To Date

2021-07-30

Local Ethnic Paper From Date

2021-07-29

Local Ethnic Paper To Date

2021-08-04

Radio/TV Ad From Date

2022-01-01 11:07:09

Radio/TV Ad To Date

2022-01-01 11:07:09

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 AND HEALTH POLICY

Foreign Worker Years of Education Completed

2010

Foreign Worker Institution of Education

MASSACHUSETTS COLLEGE OF PHARMACY AND HEALTH SCIENCES

Foreign Worker Education Institution Address 1

179 LONGWOOD 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

Attorney

Preparer Email

kliston@hebf.com

Employer Information Declaration Name

Kathleen Ellwanger

Employer Information Declaration Title

Senior Paralegal