Fiscal Year

2023

Case Number

A-22158-67806

Case Status

Certified

Received Date

2022-06-27

Decision Date

2023-03-23

Refile

N

Original File Date

2023-01-01 07:58:19

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

CARL ZEISS MEDITEC, INC.

Employer Name Slug

carl-zeiss-meditec-inc

Employer Address 1

5160 HACIENDA DRIVE

Employer Address 2

Employer City

DUBLIN

Employer City Slug

dublin

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

94568

Employer Phone

925-557-4283

Employer Number of Employees

332

Employer Year Commenced Business

1971

NAICS Code

339115

FW Ownership Interest

N

Employer Contact Name

Janice Procassini

Employer Contact Address 1

5300 Central Parkway

Employer Contact Address 2

Employer Contact City

Dublin

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

94568

Employer Contact Phone

(925) 557-4297

Employer Contact Email

janice.procassini@zeiss.com

Agent Attorney Name

Norman C Plotkin

Agent Attorney Firm Name

Jackson Hertogs LLP

Agent Attorney Phone

(415) 986-4559

Agent Attorney Address 1

909 Montgomery Street, Suite 200

Agent Attorney Address 2

Agent Attorney City

San Francisco

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

94133

Agent Attorney Email

nplotkin@jackson-hertogs.com

PW Track Number

P10021245562304

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level IV

PW Wage

116355.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-03-08

PW Expiration Date

2022-06-30

Wage Offer From

116355.00

Wage Offer To

0.00

Average Salary

116355.00

Wage Unit of Pay

Year

Worksite Address 1

5300 Central Parkway

Worksite Address 2

Worksite City

Dublin

Worksite City Slug

dublin

Worksite State

CALIFORNIA

Worksite Postal Code

94568

Job Title

Senior Regulatory Affairs Specialist

Job Title Slug

senior-regulatory-affairs-specialist

Minimum Education

Bachelor's

Major Field of Study

Drug Regulatory Affairs

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Pharmacy or related

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

60

Accept Alternative Job Title

RA Mgr, Interim RA Mgr, RA Spec, RA Associate, Quality Syst Sup or rel.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have at least 1 year of prior work experience in the following 1.Medical device Regulatory Affairs for software driven electrical medical device 2.Class I and II medical devices 510k 3.FDA requirements, guidance documents, European Union Medical Device Regulations, ISO 14971, ISO 13485, Software as a medical device, and other global regulatory requirements and quality standards. Experience must be progressively responsible.

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

2022-04-06

SWA Job Order End Date

2022-05-09

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2022-04-10

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-04-17

Employer Website From Date

2022-04-06

Employer Website To Date

2022-05-10

Professional Organization Ad From Date

2023-01-01 07:58:19

Professional Organization Advertisement To Date

2023-01-01 07:58:19

Job Search Website From Date

2022-04-08

Job Search Website To Date

2022-04-15

Employee Referral Program From Date

2023-01-01 07:58:19

Employee Referral Program To Date

2023-01-01 07:58:19

Local Ethnic Paper From Date

2022-04-13

Local Ethnic Paper To Date

2022-04-19

Radio/TV Ad From Date

2023-01-01 07:58:19

Radio/TV Ad To Date

2023-01-01 07:58:19

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

DRUG REGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

LONG ISLAND UNIVERSITY

Foreign Worker Education Institution Address 1

1 UNIVERSITY PLAZA

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BROOKLYN

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11201

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Norman C Plotkin

Preparer Title

Partner

Preparer Email

nplotkin@jackson-hertogs.com

Employer Information Declaration Name

Anita Burton

Employer Information Declaration Title

Vice President, Human Resources