All Details of Green Card Application:

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Case Number: A-21242-37716

Fiscal year: 2022

Fiscal Year

2022

Case Number

A-21242-37716

Case Status

Certified

Received Date

2021-11-21

Decision Date

2022-05-12

Refile

N

Original File Date

2022-01-01 11:26:23

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BOSTON SCIENTIFIC

Employer Name Slug

boston-scientific

Employer Address 1

300 BOSTON SCIENTIFIC WAY

Employer Address 2

Employer City

MARLBOROUGH

Employer City Slug

marlborough

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

1752

Employer Phone

508-650-8000

Employer Number of Employees

17000

Employer Year Commenced Business

1979

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Sarah Lopez

Employer Contact Address 1

300 Boston Scientific Way

Employer Contact Address 2

Employer Contact City

Marlborough

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

1752

Employer Contact Phone

508-683-4929

Employer Contact Email

[email protected]

Agent Attorney Name

Samantha D Wolfe

Agent Attorney Firm Name

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

Agent Attorney Phone

(303) 764-6831

Agent Attorney Address 1

2000 South Colorado Blvd

Agent Attorney Address 2

Tower 3, Suite 900

Agent Attorney City

Denver

Agent Attorney State/Province

COLORADO

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

80222

Agent Attorney Email

[email protected]

PW Track Number

P10020227770095

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers 119199.01

PW Skill Level

Level IV

PW Wage

164694.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-01-21

PW Expiration Date

2021-06-30

Wage Offer From

164694.00

Wage Offer To

0.00

Average Salary

164694.00

Wage Unit of Pay

Year

Worksite Address 1

100 Boston Scientific Way

Worksite Address 2

Worksite City

Marlborough

Worksite City Slug

marlborough

Worksite State

MASSACHUSETTS

Worksite Postal Code

1752

Job Title

Principal Specialist, Regulatory Affairs

Job Title Slug

principal-specialist-regulatory-affairs

Minimum Education

Master's

Major Field of Study

Regulatory Affairs

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Drug Regulatory Affairs, Biomechanical Engineering, or 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

36

Accept Alternative Job Title

Regulatory Affairs AssociateSpecialistConsultant, or related occupation.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Requires a Masters degree or Bachelors degree in Regulatory Affairs, Drug Regulatory Affairs, Biomechanical Engineering, or related field.br br Position requires progressive, postbachelors experience 3 years with Masters or 5 years with Bachelors which must include some experience in each of the following skills Training regulatory functional team members; Planning, coordinating, preparing FDA submissions 510Ks, PMAs, IDEs for new product approvalsclearances; Preparing and maintaining EU documentation including Technical Documentation in accordance with the Medical Device Directive MDD or Medical Device Regulation MDR; Experience supporting new product development projects and sustaining engineering projects for products registered in the US, EU and globally including Japan, China, and Canada; Experience conducting review of product and manufacturing changes for compliance with applicable regulations Change Control; Experience communicating with FDA, EU Competent Authorities, Notified Bodies, Health Canada, the Therapeutic Goods Administration, China FDA, and Japan PMDA to address global regulatory requirements for investigational and commercial distribution of products; and Experience with submissions and change control for medical electrical equipment capital devices, including IEC 60601 certifications.

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

2021-05-30

SWA Job Order End Date

2021-07-08

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-06-13

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-06-20

Employer Website From Date

2022-01-01 11:26:23

Employer Website To Date

2022-01-01 11:26:23

Professional Organization Ad From Date

2022-01-01 11:26:23

Professional Organization Advertisement To Date

2022-01-01 11:26:23

Job Search Website From Date

2021-06-14

Job Search Website To Date

2021-06-29

Employee Referral Program From Date

2021-06-10

Employee Referral Program To Date

2021-06-29

Local Ethnic Paper From Date

2021-06-16

Local Ethnic Paper To Date

2021-06-16

Radio/TV Ad From Date

2022-01-01 11:26:23

Radio/TV Ad To Date

2022-01-01 11:26:23

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

DRUG REGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

LONG ISLAND UNIVERSITY

Foreign Worker Education Institution Address 1

1 UNIVERSITY PLAZA

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BROOKLYN

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11201

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Samantha D Wolfe

Preparer Title

Attorney

Preparer Email

[email protected]

Employer Information Declaration Name

Sarah Lopez

Employer Information Declaration Title

Sr. HR Operations Analyst