Fiscal Year

2021

Case Number

A-20128-51646

Case Status

Certified-Expired

Received Date

2020-06-15

Decision Date

2020-12-16

Refile

N

Original File Date

2021-01-01 08:55:09

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

Victoria M Morte

Agent Attorney Firm Name

Parker Gallini LLP

Agent Attorney Phone

7818108990

Agent Attorney Address 1

460 Totten Pond Road

Agent Attorney Address 2

Suite 350

Agent Attorney City

Waltham

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2451

Agent Attorney Email

vmorte@parkergallini.com

PW Track Number

P10019259057635

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

99736.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-01-17

PW Expiration Date

2020-06-30

Wage Offer From

140004.80

Wage Offer To

0.00

Average Salary

140004.80

Wage Unit of Pay

Year

Worksite Address 1

920 Winter Street

Worksite Address 2

Worksite City

Waltham

Worksite City Slug

waltham

Worksite State

MASSACHUSETTS

Worksite Postal Code

2451

Job Title

Principal RA Associate Devices

Job Title Slug

principal-ra-associate-devices

Minimum Education

Master's

Major Field of Study

Healthcare Management, 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

Bachelor's

Accept Alternative Combination Education Years

8

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

72

Accept Alternative Job Title

Regulatory Affairs specialist in a healthcare setting

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Position requires either i a Masters degree or equivalent foreign degree in Healthcare Management, Regulatory Affairs, or a closely related field and 6 years of experience as a Regulatory Affairs specialist in a healthcare setting or ii a Bachelors degree or equivalent foreign degree in Healthcare Management, Regulatory Affairs, or a closely related field and 8 years of experience as a Regulatory Affairs specialist in a healthcare setting. Experience which can have been gained concurrently with the primary experience requirement above must include 5 years of experience with i providing interpretation of and guidance on FDA and International Medical Devices regulations and standards to medical device product teams; ii devising regulatory submission strategies; iii generating and reviewing regulatory document submissions; iv evaluating regulatory impact on existing and proposed products; v developing regulatory compliance policies; vi providing regulatory input to product life cycle planning; and vii maintaining annual licenses, registrations and listing information.br br Employer will accept any suitable combination of education, training or experience.This position requires 1015 domestic and international travel.

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

2020-02-21

SWA Job Order End Date

2020-03-27

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2020-02-23

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-03-01

Employer Website From Date

2020-02-21

Employer Website To Date

2020-03-06

Professional Organization Ad From Date

2021-01-01 08:55:09

Professional Organization Advertisement To Date

2021-01-01 08:55:09

Job Search Website From Date

2020-02-21

Job Search Website To Date

2020-02-28

Employee Referral Program From Date

2021-01-01 08:55:09

Employee Referral Program To Date

2021-01-01 08:55:09

Local Ethnic Paper From Date

2020-02-23

Local Ethnic Paper To Date

2020-02-25

Radio/TV Ad From Date

2021-01-01 08:55:09

Radio/TV Ad To Date

2021-01-01 08:55:09

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

HEALTHCARE MANAGEMENT

Foreign Worker Years of Education Completed

2008

Foreign Worker Institution of Education

UNIVERSITY OF ABERDEEN

Foreign Worker Education Institution Address 1

KINGS COLLEGE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

ABERDEEN

Foreign Worker Education Institution State/Province

SCOTLAND

Foreign Worker Education Institution Country

UNITED KINGDOM

Foreign Worker Education Institution Postal Code

AB24 3FX

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Victoria M Morte

Preparer Title

Attorney

Preparer Email

vmorte@parkergallini.com

Employer Information Declaration Name

Jeannine Foley

Employer Information Declaration Title

Sr. Assoc., Global Mobility Immigration Programs