Fiscal Year

2020

Case Number

A-19326-87130

Case Status

Certified

Received Date

2020-01-13

Decision Date

2020-05-18

Refile

N

Original File Date

2020-01-01 08:19:58

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Fresenius USA Marketing Inc

Employer Name Slug

fresenius-usa-marketing-inc

Employer Address 1

920 Winter St

Employer Address 2

Employer City

Waltham

Employer City Slug

waltham

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2451

Employer Phone

781-6999459

Employer Number of Employees

62679

Employer Year Commenced Business

1999

NAICS Code

621399

FW Ownership Interest

N

Employer Contact Name

Jeannine Foley

Employer Contact Address 1

920 Winter St

Employer Contact Address 2

Employer Contact City

Waltham

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2451

Employer Contact Phone

781-6999459

Employer Contact Email

jeannine.foley@fmc-na.com

Agent Attorney Name

Donald W Parker

Agent Attorney Firm Name

Parker Gallini LLP

Agent Attorney Phone

7818108990

Agent Attorney Address 1

460 Totten Pond Road

Agent Attorney Address 2

Agent Attorney City

Waltham

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2451

Agent Attorney Email

dparker@parkergallini.com

PW Track Number

P10019142534395

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

159744.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-09-10

PW Expiration Date

2020-06-30

Wage Offer From

160659.20

Wage Offer To

0.00

Average Salary

160659.20

Wage Unit of Pay

Year

Worksite Address 1

920 Winter St.

Worksite Address 2

Worksite City

Waltham

Worksite City Slug

waltham

Worksite State

MASSACHUSETTS

Worksite Postal Code

2451

Job Title

Manager, Regulatory Affairs, Devices

Job Title Slug

manager-regulatory-affairs-devices

Minimum Education

Bachelor's

Major Field of Study

Regulatory Affairs or a closely 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

3

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Regulatory Affairs Associate

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

This position requires either a Bachelors degree or an equivalent foreign degree in Regulatory Affairs or a closely related field and 5 years of experience as a Regulatory Affairs Associate or a Masters degree or an equivalent foreign degree in Regulatory Affairs or a closely related field and 3 years of experience as a Regulatory Affairs Associate. Must also have had experience which can be gained concurrently with either of the primary experience requirements above with i implementing compliance procedures and practices in regards to applicable international and United States federal laws; ii ensuring compliance of corporatelevel policies and procedures with applicable FDA regulations and ISO standards; and iii drafting and preparing Premarket Notification 510k submissions to the FDA.

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

2019-09-16

SWA Job Order End Date

2019-10-18

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2019-09-15

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-09-22

Employer Website From Date

2019-09-14

Employer Website To Date

2019-10-01

Professional Organization Ad From Date

2020-01-01 08:19:58

Professional Organization Advertisement To Date

2020-01-01 08:19:58

Job Search Website From Date

2019-09-17

Job Search Website To Date

2019-09-24

Employee Referral Program From Date

2020-01-01 08:19:58

Employee Referral Program To Date

2020-01-01 08:19:58

Local Ethnic Paper From Date

2019-09-20

Local Ethnic Paper To Date

2019-09-22

Radio/TV Ad From Date

2020-01-01 08:19:58

Radio/TV Ad To Date

2020-01-01 08:19:58

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 AFFAIRS

Foreign Worker Years of Education Completed

2012

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Donald W Parker

Preparer Title

Attorney

Preparer Email

DParker@parkergallini.com

Employer Information Declaration Name

Jeannine Foley

Employer Information Declaration Title

Sr. Assoc., Global Mobility Immigration Programs