Fiscal Year

2024

Case Number

A-23061-07735

Case Status

Certified

Received Date

2023-05-04

Decision Date

2024-05-22

Refile

N

Original File Date

2024-01-01 01:23:16

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BAYER U.S. LLC

Employer Name Slug

bayer-us-llc

Employer Address 1

100 BAYER BOULEVARD

Employer Address 2

Employer City

WHIPPANY

Employer City Slug

whippany

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7981

Employer Phone

412-777-2375

Employer Number of Employees

15800

Employer Year Commenced Business

2008

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Alex Greenberg

Employer Contact Address 1

800 N. Lindbergh Blvd.

Employer Contact Address 2

Employer Contact City

St. Louis

Employer Contact State/Province

MISSOURI

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

63167

Employer Contact Phone

3142439968

Employer Contact Email

alex.greenberg1@bayer.com

Agent Attorney Name

Alexander R Castrodale

Agent Attorney Firm Name

Dentons Cohen Grigsby, P.C.

Agent Attorney Phone

4122974712

Agent Attorney Address 1

625 Liberty Avenue

Agent Attorney Address 2

Flr. 5

Agent Attorney City

Pittsburgh

Agent Attorney State/Province

PENNSYLVANIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

15222

Agent Attorney Email

alex.castrodale@dentons.com

PW Track Number

P10022220402607

PW SOC Code

11-9199.01

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

158226.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2023-02-22

PW Expiration Date

2023-06-30

Wage Offer From

158226.00

Wage Offer To

0.00

Average Salary

158226.00

Wage Unit of Pay

Year

Worksite Address 1

1 Bayer Drive

Worksite Address 2

Worksite City

Indianola

Worksite City Slug

indianola

Worksite State

PENNSYLVANIA

Worksite Postal Code

15051

Job Title

Senior Manager Global Regulatory Strategy Device Life Cycle

Job Title Slug

senior-manager-global-regulatory-strategy-device-life-cycle

Minimum Education

Bachelor's

Major Field of Study

Biomedical Engineering or a related field.

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

4

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

72

Accept Alternative Job Title

postbaccalaureate and progressively responsible experience in a related position

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

First Alternate Education and Experience A masters degree or foreign equivalent degree in Biomedical Engineering or a related field plus four 4 years of experience in a related position.br br Second Alternate Education and Experience A Ph.D. or foreign equivalent degree in Biomedical Engineering, or a related field plus two 2 years of experience in a related position.br br Must also have any experience with or knowledge of i interacting with Regulatory Affairs and crossfunctional partners to create Regulatory strategies in support of both new product development and life cycle engineering significant change submissions for MR modality Radiology products to countries within APAC, LATAM and EMEA, including technical documents, and dossiers needed to gain product clearance; ii global medical device regulations that are applicable to MR Radiology products, both electromechanical and sterile disposables; iii MR medical device Quality Systems and supporting Internal Audits; iv coordinating technical assessments for MR products in support of EU MDR certification for review by a notified body ; and v 21 CFR 820, EU MDR, EU MDD, ISO 14971, ISO 13485, ISO 10993, MDRs, Regulatory Statement of Conformity RSoC; vi MR Labeling and promotional material review to ensure compliance to global regulatory requirements; vii reviewing customer complaints for safety issues; nonconformances and CAPAs for effectiveness; viii preparing 510K submissions to the U.S. FDA; and ix regulatory registration requirements to support global submission dossiers for MR electromechanical, sterile disposable and software products.br br Experience can be concurrent.br br Note Since there is no experience required in H.6, the Kellogg Language is not required.

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

2023-02-17

SWA Job Order End Date

2023-03-21

Sunday Edition Newspaper

Y

First Newspaper Name

Pittsburgh PostGazette

First Advertisement Start Date

2023-02-26

Second Newspaper Ad Name

Pittsburgh PostGazette

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-03-05

Employer Website From Date

2023-02-16

Employer Website To Date

2023-03-21

Professional Organization Ad From Date

2024-01-01 01:23:16

Professional Organization Advertisement To Date

2024-01-01 01:23:16

Job Search Website From Date

2023-02-25

Job Search Website To Date

2023-03-10

Employee Referral Program From Date

2024-01-01 01:23:16

Employee Referral Program To Date

2024-01-01 01:23:16

Local Ethnic Paper From Date

2023-03-01

Local Ethnic Paper To Date

2023-03-01

Radio/TV Ad From Date

2024-01-01 01:23:16

Radio/TV Ad To Date

2024-01-01 01:23:16

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

BIOMEDICAL ENGINEERING

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

CLEVELAND STATE UNIVERSITY

Foreign Worker Education Institution Address 1

2121 EUCLID AVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CLEVELAND

Foreign Worker Education Institution State/Province

OH

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

44115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Alexander R Castrodale

Preparer Title

Attorney

Preparer Email

alex.castrodale@dentons.com

Employer Information Declaration Name

Alex Greenberg

Employer Information Declaration Title

Senior Immigration Specialist