Fiscal Year

2023

Case Number

A-22287-39998

Case Status

Withdrawn

Received Date

2022-10-28

Decision Date

2023-03-06

Refile

N

Original File Date

2023-01-01 08:02:50

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Fresenius USA Marketing, Inc., a FMCNA company

Employer Name Slug

fresenius-usa-marketing-inc-a-fmcna-company

Employer Address 1

920 Winter Street

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

7816999459

Employer Number of Employees

62679

Employer Year Commenced Business

1996

NAICS Code

621399

FW Ownership Interest

N

Employer Contact Name

Molly Stout

Employer Contact Address 1

920 Winter Street

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

7816999459

Employer Contact Email

molly.stout@freseniusmedicalcare.com

Agent Attorney Name

Donald W Parker

Agent Attorney Firm Name

Parker Gallini LLP

Agent Attorney Phone

7818108990

Agent Attorney Address 1

400 Fifth Avenue

Agent Attorney Address 2

Suite 401

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

P10021237545738

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level I

PW Wage

58219.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-02-25

PW Expiration Date

2022-06-30

Wage Offer From

104582.81

Wage Offer To

0.00

Average Salary

104582.81

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

Regulatory Affairs Associate – Devices

Job Title Slug

regulatory-affairs-associate-devices

Minimum Education

Master's

Major Field of Study

Regulatory Affairs, Pharmacy, Biochemistry, 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

2

Accept Foreign Education

Y

Accept Alternative Occupation

N

Accept Alternative Occupation Months

Accept Alternative Job Title

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

This position requires a Masters degree or foreign equivalent in Regulatory Affairs, Pharmacy, Biochemistry, or a closely related field. Alternatively, will accept a Bachelors degree or foreign equivalent in Regulatory Affairs, Pharmacy, Biochemistry or a closely related field and two 2 years of experience developing and reviewing regulatory strategies and submissions for medical devices.br br Experience, which may have been gained concurrently with the primary experience requirement above through professional or graduatelevel academic experience, must includebr br Assisting with the preparation of regulatory documentation packages for submission to regulatory agencies including investigational device exemptions IDSs, premarket approval, and 510k submissions.br Creating and updating internal regulatory control processes, including documentation workflow and standard operation procedures SOPs in accordance with FDA guidance documentation.br Verifying the compliance of regulatory submissions with format and content standards before submitting to the U.S. FDA.br br This position requires 25 30 travel. This is a telecommuting position working from home, may reside anywhere in the United States.br br br From H.8C., type of the acceptable experience for the alternate combination of education and experience 2 years of experience developing and reviewing regulatory strategies and submissions for medical devices.

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

2022-08-03

SWA Job Order End Date

2022-09-05

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2022-06-05

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-06-12

Employer Website From Date

2022-05-26

Employer Website To Date

2022-06-17

Professional Organization Ad From Date

2023-01-01 08:02:50

Professional Organization Advertisement To Date

2023-01-01 08:02:50

Job Search Website From Date

2022-05-26

Job Search Website To Date

2022-06-02

Employee Referral Program From Date

2023-01-01 08:02:50

Employee Referral Program To Date

2023-01-01 08:02:50

Local Ethnic Paper From Date

2022-06-03

Local Ethnic Paper To Date

2022-06-05

Radio/TV Ad From Date

2023-01-01 08:02:50

Radio/TV Ad To Date

2023-01-01 08:02:50

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

REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

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

Molly Stout

Employer Information Declaration Title

Supervisor, Global Mobility Immigration Programs