Fiscal Year

2020

Case Number

A-19349-95716

Case Status

Certified

Received Date

2019-12-19

Decision Date

2020-05-07

Refile

N

Original File Date

2020-01-01 08:24:43

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BECTON DICKINSON AND COMPANY

Employer Name Slug

becton-dickinson-and-company

Employer Address 1

1 BECTON DRIVE

Employer Address 2

Employer City

FRANKLIN LAKES

Employer City Slug

franklin-lakes

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7417

Employer Phone

1.201.847.7332

Employer Number of Employees

41933

Employer Year Commenced Business

1897

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

YEN LE BAVIS

Employer Contact Address 1

1 Becton Drive

Employer Contact Address 2

Employer Contact City

Franklin Lakes

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

7417

Employer Contact Phone

1.8586174035

Employer Contact Email

GMB-US-Domestic-Immigration@bd.com

Agent Attorney Name

Melina V Villalobos

Agent Attorney Firm Name

Ogletree, Deakins, Nash, Smoak Stewart, P.C.

Agent Attorney Phone

919-787-9700

Agent Attorney Address 1

8529 Six Forks Road, Fourm IV

Agent Attorney Address 2

Suite 600

Agent Attorney City

RALEIGH

Agent Attorney State/Province

NORTH CAROLINA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

27615

Agent Attorney Email

melina.villalobos@ogletree.com

PW Track Number

P10019221037612

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

79394.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-12-09

PW Expiration Date

2020-06-30

Wage Offer From

128289.00

Wage Offer To

0.00

Average Salary

128289.00

Wage Unit of Pay

Year

Worksite Address 1

2350 Qume Drive

Worksite Address 2

Worksite City

San Jose

Worksite City Slug

san-jose

Worksite State

CALIFORNIA

Worksite Postal Code

95131

Job Title

Regulatory Affairs Project Manager

Job Title Slug

regulatory-affairs-project-manager

Minimum Education

Master's

Major Field of Study

Biomedical Regulatory Affairs

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Related field

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

In the job offered or related occupation.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Must also have demonstrated experience in the following Identifying regulatory activities for project schedules, providing a high level of regulatory expertise and experience to the unitsegment complex programs, serving as an RA team member and recommending appropriate actions on regulatory issues; Participating in business interactions and negotiations with regulatory agencies on premarket submission requirements; Reviewing product development and clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance including the use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale. Participate in functional, data, and design reviews; Working on problems of high complexity and diverse scope, in which data analysis requires evaluation of identifiable factors; Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions; Serve an RA team member for promotional materials review, experimental designs, data analysis, and product labeling as they relate to registration and commercialization of medical devices; and Must present results verbally and in writing. Work independently as well as part of a team. Bring Regulatory Affairs questionsissues to the attention of RA management.

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

2019-08-30

SWA Job Order End Date

2019-09-30

Sunday Edition Newspaper

Y

First Newspaper Name

The Mercury News

First Advertisement Start Date

2019-09-15

Second Newspaper Ad Name

The Mercury News

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-09-22

Employer Website From Date

2020-01-01 08:24:43

Employer Website To Date

2020-01-01 08:24:43

Professional Organization Ad From Date

2020-01-01 08:24:43

Professional Organization Advertisement To Date

2020-01-01 08:24:43

Job Search Website From Date

2019-09-15

Job Search Website To Date

2019-09-29

Employee Referral Program From Date

2020-01-01 08:24:43

Employee Referral Program To Date

2020-01-01 08:24:43

Local Ethnic Paper From Date

2019-09-20

Local Ethnic Paper To Date

2019-09-20

Radio/TV Ad From Date

2019-09-19

Radio/TV Ad To Date

2019-09-19

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CHINA

Foreign Worker Birth Country

CHINA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

BIOMEDICAL REGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

THE UNIVERSITY OF WASHINGTON

Foreign Worker Education Institution Address 1

4109 E STEVENS WAY NE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

SEATTLE

Foreign Worker Education Institution State/Province

WA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

98105

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Melina V Villalobos

Preparer Title

Attorney

Preparer Email

melina.villalobos@ogletree.com

Employer Information Declaration Name

Lynda Fouts

Employer Information Declaration Title

Manager, HR Compliance