Fresenius USA Marketing, Inc., a FMCNA company

Regulatory Affairs Associate – Devices

A-22287-39998 H-1B 2023 Withdrawn

Salary

$58,219

Visa Type

H-1B

Job Title

Regulatory Affairs Associate – Devices

Employee's Citizenship

INDIA

Graduate School

NORTHEASTERN UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish 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Case Status Withdrawn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 -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name Fresenius USA Marketing, Inc., a FMCNA company

Employer Address_Line 1 920 Winter Street

Employer Address_Line 2 -

Employer City Waltham

State -

Employer State/ Province MASSACHUSETTS

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 2451

Employer Phone No. 7816999459

Employer Phone Extent No. -

Total Number of Employees 62679

Employer Year of Commenced 1996

NAICS Code 621399

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Molly Stout

Employer Contact Address Line1 920 Winter Street

Employer Contact Address Line2 -

Employer Contact City Waltham

Employer Contact State/ Provice MASSACHUSETTS

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 2451

Employer Contact Phone 7816999459

Employer Contact Email molly.stout@freseniusmedicalcare.com

Attorney

11 fields

Agent/ Attorney Name Donald W Parker

Agent/ Attorney Firm Name Parker Gallini LLP

Agent/ Attorney Phone 7818108990

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 400 Fifth Avenue

Agent/ Attorney Address Line 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

Position Info

89 fields

Prevailing Wage Track Number P10021237545738

Prevailing Wage SOC Code 13-1041

Prevailing Wage SOC Title Compliance Officers

Prevailing Wage Skill Level Level I

Prevailing Wage 58219

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-02-25

Prevailing Wage Expiration Date 2022-06-30

Wage Offer From 104583

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 920 Winter Street

Worksite Address Line 2 -

Worksite City Waltham

Worksite State MASSACHUSETTS

Worksite Postal Code 2451

Job Title Regulatory Affairs Associate – Devices

Minimum Education Master's

Other Degree/ Diploma -

Major Field of Study Regulatory Affairs, Pharmacy, Biochemistry, or a closely related field

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

Accept Alternate Field of Study N

Accept Alternate Major -

Alternate Combination of Education/ Experience Y

Required Alternate Level of Education Bachelor's

Other Alternate Level of Education -

Acceptable Years of Experience 2

Accept Foreign Educationa Y

Acceptable Alternate Occupation N

Acceptable Alternate Occupation Month -

Accept Alternate Job Title -

Normal Requirements of Job Opportunity Y

Required Foreign Language 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 Applied Foreign Worker Y

ForeignWorker Live on Premises N

Live in Domestic Service Worker N

Employment Contract -

Professional Occupation Y

College/ University Teacher N

Competitive Process -

Basic Recruitment Process -

Teacher Select Date -

Teacher Publish Journal Name -

Additional Recruitment Information -

Job Oder Start Date 2022-08-03

Job Oder End Date 2022-09-05

Sunday Edition Newspaper Y

First Newspaper Name Boston Globe

First Advertisement Start Date 2022-06-05

Second Newspaper Name Boston Globe

Second Advertisement Type Newspaper

Second Ad Start Date 2022-06-12

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2022-05-26

Employer Website to Date 2022-06-17

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-05-26

Job Search Website to Date 2022-06-02

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date -

Employee Referral Program to Date -

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-06-03

Local Ethnic Newspaper to Date 2022-06-05

Radio/TV Ad from Date -

Radio/TV Ad to Date -

Employer Received the Payment N

Payment Details -

Bargaining Representative Notified N/A

Posted Notice at Worksite Y

Layoff in Past Six Months N

US Worker Considered -

Country of Citizenship INDIA

Foreign Worker Birth Country INDIA

Class of Admission H-1B

Employee Info

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Year of Compelted Education 2016

Foreign Worker Istitution of Eduation NORTHEASTERN UNIVERSITY

Foreign Worker Education Instution Address Line 1 360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City BOSTON

Foreign Worker Educatution Institution State MA

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 2115

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N/A

Foreign Worker Alternate Education and Experience N

Foreign Worker Alternate Occupation Experience N/A

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay 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 Declaration Title Supervisor, Global Mobility Immigration Programs