Fiscal Year

2024

Case Number

A-23025-92966

Case Status

Certified-Expired

Received Date

2023-03-17

Decision Date

2024-04-02

Refile

N

Original File Date

2024-01-01 00:57:33

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BOSTON SCIENTIFIC CORPORATION

Employer Name Slug

boston-scientific-corporation

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

5086834829

Employer Number of Employees

41000

Employer Year Commenced Business

1979

NAICS Code

33911

FW Ownership Interest

N

Employer Contact Name

Tow Christopher

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

5086834829

Employer Contact Email

Christopher.Tow@bsci.com

Agent Attorney Name

John F LEsperance

Agent Attorney Firm Name

Duane Morris LLP

Agent Attorney Phone

5619622114

Agent Attorney Address 1

1875 NW Corporate Boulevard

Agent Attorney Address 2

Ste 300

Agent Attorney City

Boca Raton

Agent Attorney State/Province

FLORIDA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

33431

Agent Attorney Email

jlesperance@duanemorris.com

PW Track Number

P10022129150681

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level II

PW Wage

74173.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-11-30

PW Expiration Date

2023-06-30

Wage Offer From

74173.00

Wage Offer To

115000.00

Average Salary

94586.50

Wage Unit of Pay

Year

Worksite Address 1

300 Boston Scientific Way

Worksite Address 2

May require to traveltelecommute.

Worksite City

Marlborough

Worksite City Slug

marlborough

Worksite State

MASSACHUSETTS

Worksite Postal Code

1752

Job Title

Regulatory Affairs Specialist II

Job Title Slug

regulatory-affairs-specialist-ii

Minimum Education

Master's

Major Field of Study

Information Technology, Biomedical Engineering, Biomedical Technology or related technical field

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Information Technology, Biomedical Engineering, Biomedical Technology or related technical field

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

Job Offered or a related occupation

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Employer requires a Masters degree in Information Technology, Biomedical Engineering, Biomedical Technology, or related technical field plus 24 months experience in job offered, or related occupation. Experience must include 1 working on Regulatory Affairs life cycle of a medical device from concept through planning, design, validation and launch to post market, 2 working with EU Class IIa, Class IIb and US Class II devices, 3 Submission experience working with EU Notified Bodies, 4 Supporting Product Lifecycle Management projects for a variety of EU medical devices, by evaluating the change and drafting regulatory strategies for the crossfunctional teams to understand the regulatory impact for US, EU and Rest of the World, 5 Providing regulatory expertise for CAPAs, cost improvement, process improvement projects and author required Competent Authority submissions, 6 Preparing and submitting Significant and NonSignificant change supplements to Notified Bodies EU and 510ksubmissions to FDA US and function as the point of contact for these regulatory authorities, 7 Updating Technical Documentation for medical device products according to the MDR requirements as well as the Declaration of Conformity, and, 8 Creating the GSPR by coordinating with the cross functional teams for evidence documentation for conformity and references to the products Technical Documentation.

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

2022-12-04

SWA Job Order End Date

2023-01-09

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Sunday Globe

First Advertisement Start Date

2022-12-18

Second Newspaper Ad Name

Boston Sunday Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-12-25

Employer Website From Date

2024-01-01 00:57:33

Employer Website To Date

2024-01-01 00:57:33

Professional Organization Ad From Date

2024-01-01 00:57:33

Professional Organization Advertisement To Date

2024-01-01 00:57:33

Job Search Website From Date

2022-12-04

Job Search Website To Date

2022-12-21

Employee Referral Program From Date

2024-01-01 00:57:33

Employee Referral Program To Date

2024-01-01 00:57:33

Local Ethnic Paper From Date

2022-12-15

Local Ethnic Paper To Date

2022-12-15

Radio/TV Ad From Date

2022-12-16

Radio/TV Ad To Date

2022-12-16

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

INFORMATION TECHNOLOGY

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

WORCESTER POLYTECHNIC INSTITUTE

Foreign Worker Education Institution Address 1

100 INSTITUTE RD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

WORCESTER

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

1609

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

JOHN F LESPERANCE

Preparer Title

PARTNER

Preparer Email

JLESPERANCE@DUANEMORRIS.COM

Employer Information Declaration Name

CHRISTOPHER TOW

Employer Information Declaration Title

SENIOR HR OPERATIONS ANALYST