Fiscal Year

2021

Case Number

A-20192-75054

Case Status

Certified-Expired

Received Date

2020-07-13

Decision Date

2021-02-12

Refile

N

Original File Date

2021-01-01 09:01:50

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

GREINER BIOONE NORTH AMERICA INC.

Employer Name Slug

greiner-bioone-north-america-inc

Employer Address 1

4238 CAPITAL DRIVE

Employer Address 2

Employer City

MONROE

Employer City Slug

monroe

Employer State

NORTH CAROLINA

Employer State Slug

north-carolina

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

28110

Employer Phone

704-261-7882

Employer Number of Employees

365

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Daphne K Babay

Employer Contact Address 1

4238 Capital Drive

Employer Contact Address 2

Employer Contact City

Monroe

Employer Contact State/Province

NORTH CAROLINA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

28110

Employer Contact Phone

704-261-7882

Employer Contact Email

daphne.babay@gbo.com

Agent Attorney Name

Stephen Hader

Agent Attorney Firm Name

Moore Van Allen, PLLC

Agent Attorney Phone

(704) 331-1139

Agent Attorney Address 1

100 North Tryon Street

Agent Attorney Address 2

4700

Agent Attorney City

Charlotte

Agent Attorney State/Province

NORTH CAROLINA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

28202

Agent Attorney Email

stevehader@mvalaw.com

PW Track Number

P10019316139318

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

53165.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-03-05

PW Expiration Date

2020-06-30

Wage Offer From

76500.00

Wage Offer To

0.00

Average Salary

76500.00

Wage Unit of Pay

Year

Worksite Address 1

4238 Capital Drive

Worksite Address 2

Worksite City

Monroe

Worksite City Slug

monroe

Worksite State

NORTH CAROLINA

Worksite Postal Code

28110

Job Title

Regulatory Affairs Specialist

Job Title Slug

regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Medical Technology

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Pharmacy Administration or related life sci field

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

N

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

Regulatory Affairs Specialist

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

industry experience as Regulatory Affairs Specialist with experience and expertise in compliance with FDA regulations for product labeling; evaluating information to determine compliance with standards and regulations; coordinating, preparing, reviewing, submitting regulatory submissions; supporting projects in domestic and international markets. Must include documentationmaintenance for regulatory technical files to obtainsustain product clearances; communication with FDA, other regulatory agencies for presubmission, compliance testing, clarification, followup submissions; eCTD submission for Master Files in FDA; Quality Audits; recall activities and FDA adverse event or Medical device reporting activities for marketed product; Annual Report Submission to FDA for amendments and supplements. 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

2020-03-12

SWA Job Order End Date

2020-04-27

Sunday Edition Newspaper

Y

First Newspaper Name

Charlotte Observer

First Advertisement Start Date

2020-04-12

Second Newspaper Ad Name

Charlotte Observer

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-04-19

Employer Website From Date

2020-04-03

Employer Website To Date

2020-04-20

Professional Organization Ad From Date

2021-01-01 09:01:50

Professional Organization Advertisement To Date

2021-01-01 09:01:50

Job Search Website From Date

2020-04-16

Job Search Website To Date

2020-04-30

Employee Referral Program From Date

2021-01-01 09:01:50

Employee Referral Program To Date

2021-01-01 09:01:50

Local Ethnic Paper From Date

2020-04-16

Local Ethnic Paper To Date

2020-04-16

Radio/TV Ad From Date

2021-01-01 09:01:50

Radio/TV Ad To Date

2021-01-01 09:01:50

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

PHARMACY ADMINISTRATION REGULATORY AFFAIRS QUALITY ASSURANCE

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

ST. JOHNS UNIVERSITY

Foreign Worker Education Institution Address 1

8000 UTOPIA PARKWAY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

JAMAICA

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11439

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Stephen Hader

Preparer Title

Attorney

Preparer Email

stevehader@mvalaw.com

Employer Information Declaration Name

Daphne Babay

Employer Information Declaration Title

HR Assistant ManagerBenefit Administrator