BOSTON SCIENTIFIC CORPORATION

Director, Regulatory Affairs

A-22244-15531 H-1B 2023 Certified

Salary

$136,490

Visa Type

H-1B

Job Title

Director, Regulatory Affairs

Employee's Citizenship

INDIA

Graduate School

UNIVERSITY OF SOUTHERN CALIFORNIA

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22244-15531

Case Status Certified

Received Date 2022-09-23

Decision Date 2023-08-18

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 BOSTON SCIENTIFIC CORPORATION

Employer Address_Line 1 300 BOSTON SCIENTIFIC WAY

Employer Address_Line 2 -

Employer City MARLBOROUGH

State -

Employer State/ Province MASSACHUSETTS

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 1752

Employer Phone No. 5086834829

Employer Phone Extent No. -

Total Number of Employees 41000

Employer Year of Commenced 1979

NAICS Code 33911

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Tow Christopher

Employer Contact Address Line1 300 Boston Scientific Way

Employer Contact Address Line2 -

Employer Contact City Marlborough

Employer Contact State/ Provice MASSACHUSETTS

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 1752

Employer Contact Phone 5086834829

Employer Contact Email Christopher.Tow@bsci.com

Attorney

11 fields

Agent/ Attorney Name John F LEsperance

Agent/ Attorney Firm Name Duane Morris LLP

Agent/ Attorney Phone 5619622114

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 1875 NW Corporate Boulevard

Agent/ Attorney Address Line 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

Position Info

89 fields

Prevailing Wage Track Number P10021354775726

Prevailing Wage SOC Code 11-9199

Prevailing Wage SOC Title Regulatory Affairs Manager

Prevailing Wage Skill Level Level II

Prevailing Wage 136490

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-06-17

Prevailing Wage Expiration Date 2022-09-15

Wage Offer From 136490

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 3715 Haven Avenue, Suite 110

Worksite Address Line 2 May require to traveltelecommute.

Worksite City Menlo Park

Worksite State CALIFORNIA

Worksite Postal Code 94025

Job Title Director, Regulatory Affairs

Minimum Education Master's

Other Degree/ Diploma -

Major Field of Study Biomedical Engineering, Chemical Engineering, or related technical field.

Required Training N

Required Training Month -

Required Field of Training -

Required Experience Y

Required Expreience Months 10

Accept Alternate Field of Study Y

Accept Alternate Major Biomedical Engineering, Chemical Engineering, or related technical field.

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 10

Accept Alternate Job Title Job offered, Regulatory Affairs Manager, Regulatory Affairs Specialist or related occupation.

Normal Requirements of Job Opportunity N

Required Foreign Language N

Specific Skills employer requires a Masters degree in Biomedical Engineering, Chemical Engineering, or related technical field plus 10 months of experience in job offered, Regulatory Affairs Manager, Regulatory Affairs Specialist or related occupation. Experience must include 1 Developing worldwide regulatory strategic level plans and complete premarket and postmarket regulatory submissions for Class II and III medical devices, including project planning, 2 Regulatory affairs experience successfully working on Class II III devices submissions such as IDEs, 510k, PMA, Presubmissions, Technical File, and Design Dossiers, 3 Proven track record of direct experience in interfacing with the FDA, notified body NB, other global health authorities, 4 Strong knowledge of FDA, EU, Health Canada and other applicable international regulatory requirements including clinical trial requirements, quality system requirements, submission requirements, labeling and promotion requirements, 5 Experience in reviewing and supporting crossfunctional teams on usability testing, 6 Broad knowledge of crossfunctional areas including Quality, Clinical Affairs, Program Management, Manufacturing and Product Development, and 7 Supervisory experience in regulatory affairs.

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 2022-07-13

Job Oder End Date 2022-08-17

Sunday Edition Newspaper Y

First Newspaper Name SAN FRANCISCO CHRONICLE

First Advertisement Start Date 2022-07-03

Second Newspaper Name SAN FRANCISCO CHRONICLE

Second Advertisement Type Newspaper

Second Ad Start Date 2022-07-10

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date -

Employer Website to Date -

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-06-28

Job Search Website to Date 2022-07-12

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 2022-07-06

Local Ethnic Newspaper to Date 2022-07-12

Radio/TV Ad from Date 2022-07-05

Radio/TV Ad to Date 2022-07-05

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 BIOMEDICAL ENGINEERING

Year of Compelted Education 2008

Foreign Worker Istitution of Eduation UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Instution Address Line 1 UNIVERSITY PARK

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City LOS ANGELES

Foreign Worker Educatution Institution State CA

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 90089

Foreign Worker Training Completion N/A

Foreign Worker Required Experience Y

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay 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 Declaration Title SR HR OPERATIONS ANALYST