Fiscal Year

2021

Case Number

A-21012-41336

Case Status

Certified

Received Date

2021-01-19

Decision Date

2021-06-30

Refile

N

Original File Date

2021-01-01 09:44:47

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ZIMMER INC

Employer Name Slug

zimmer-inc

Employer Address 1

PO BOX 708

Employer Address 2

345 E MAIN ST

Employer City

WARSAW

Employer City Slug

warsaw

Employer State

INDIANA

Employer State Slug

indiana

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

46581

Employer Phone

574-372-6626

Employer Number of Employees

19900

Employer Year Commenced Business

1927

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Lena Byanski

Employer Contact Address 1

56 E Bell Dr

Employer Contact Address 2

Employer Contact City

Warsaw

Employer Contact State/Province

INDIANA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

46582

Employer Contact Phone

574-373-3737

Employer Contact Email

Lena.Byanski@zimmerbiomet.com

Agent Attorney Name

Jay C Ruby

Agent Attorney Firm Name

Agent Attorney Phone

6785532295

Agent Attorney Address 1

3333 Piedmont Road NE

Agent Attorney Address 2

SUITE 2500

Agent Attorney City

ATLANTA

Agent Attorney State/Province

GEORGIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

30305

Agent Attorney Email

rubyj@gtlaw.com

PW Track Number

P10020183691183

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

134742.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-11-25

PW Expiration Date

2021-06-30

Wage Offer From

134742.00

Wage Offer To

0.00

Average Salary

134742.00

Wage Unit of Pay

Year

Worksite Address 1

1800 W. Center Street

Worksite Address 2

Worksite City

Warsaw

Worksite City Slug

warsaw

Worksite State

INDIANA

Worksite Postal Code

46580

Job Title

Regulatory Affairs Manager

Job Title Slug

regulatory-affairs-manager

Minimum Education

Bachelor's

Major Field of Study

Life Sciences, Engineering, or related

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

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

72

Accept Alternative Job Title

any job in which exp w min reqs gained

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Requires a Bachelors degree or foreign equivalent degree in life sciences, engineering, or a related field and 6 years experience managing systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. Also requires 6 years of experience authoring and publishing electronic RA submissions; with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products and interpreting results of research; interpreting and applying FDA regulations to business practices and providing regulatory input, advice, and guidance to the organization; training entrylevel associates, interns, specialists, and project managers; with assigning regulatory affairs development project teams as well as developing regulatory strategy for new products; writing, managing, and approving the development of package inserts; and reviewing, evaluating, and approving promotion and advertising material for compliance with applicable regulations.

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

2020-07-29

SWA Job Order End Date

2020-08-31

Sunday Edition Newspaper

Y

First Newspaper Name

The Journal Gazette Fort Wayne

First Advertisement Start Date

2020-07-26

Second Newspaper Ad Name

The Journal Gazette Fort Wayne

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-08-02

Employer Website From Date

2020-07-24

Employer Website To Date

2020-09-24

Professional Organization Ad From Date

2021-01-01 09:44:47

Professional Organization Advertisement To Date

2021-01-01 09:44:47

Job Search Website From Date

2020-07-24

Job Search Website To Date

2020-07-31

Employee Referral Program From Date

2021-01-01 09:44:47

Employee Referral Program To Date

2021-01-01 09:44:47

Local Ethnic Paper From Date

2020-07-29

Local Ethnic Paper To Date

2020-07-29

Radio/TV Ad From Date

2021-01-01 09:44:47

Radio/TV Ad To Date

2021-01-01 09:44:47

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 SCIENCE

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

THE UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

Foreign Worker Education Institution Address 2

JOHN HUBBARD HALL 106

Foreign Worker Education Institution City

LOS ANGELES

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

90089

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Jay C Ruby

Preparer Title

Shareholder

Preparer Email

rubyj@gtlaw.com

Employer Information Declaration Name

Lena Byanski

Employer Information Declaration Title

Immigration Specialist