Fiscal Year

2023

Case Number

A-22026-03236

Case Status

Certified

Received Date

2022-03-13

Decision Date

2022-11-22

Refile

N

Original File Date

2023-01-01 18:08:50

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

marie.foti-fleischer@bsci.com

Agent Attorney Name

Ann H Lee

Agent Attorney Firm Name

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

Agent Attorney Phone

303-318-7487

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

ann.lee@ogletree.com

PW Track Number

P10021061114635

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialist 131041.07

PW Skill Level

Level I

PW Wage

52832.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-07-27

PW Expiration Date

2022-06-30

Wage Offer From

55500.00

Wage Offer To

105400.00

Average Salary

80450.00

Wage Unit of Pay

Year

Worksite Address 1

25155 Rye Canyon Loop

Worksite Address 2

Worksite City

Valencia

Worksite City Slug

valencia

Worksite State

CALIFORNIA

Worksite Postal Code

91355

Job Title

Specialist I, Reg Affairs

Job Title Slug

specialist-i-reg-affairs

Minimum Education

Bachelor's

Major Field of Study

Management of Drug Development

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Regulatory Affairs or related 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

Assoc.Sp. Reg. Affairs, Reg. Coordinator, PharmacistReg. Affairs, Pharmacist, or rel. occupation

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Section H. 10B Identify the job title or the acceptable alternate occupation AssociateSpecialist Regulatory Affairs, Regulatory Coordinator, PharmacistRegulatory Affairs, Pharmacist, or related occupation.br br Requires a Bachelors degree in Management of Drug Development, Regulatory Affairs or related field.br br Position requires 2 years of related experience, which must include some experience in each of the following skills Work with device reviewers through verbal and written communications regarding presubmission strategyregulatory pathway development, testing requirements, clarification and followup of submissions under review; Assist in drafting regulatory strategies for new and modified medical devices; Assist reviews and signoff on product and manufacturing changes for compliance with applicable regulations; Provide Regulatory Affairs feedback and guidance throughout the product development cycle; Assist with the preparation and submission of regulatory applications, as well as internal regulatory file documentation; Collaborate with international countries on medical devices registration and submission; Review medical device labeling product label and Instruction for Use, that is complaint to ISO 152231; US FDA Class II 510 k preparation and submission experience; US FDA PMA post approval change assessment and submission experience; Experience with US FDA Establishment Registration Device Listing; and Experience with IEC 606011 Medical Electrical Equipment and IEC 6060112 Electromagnetic Compatibility testing.

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

2021-11-14

SWA Job Order End Date

2021-12-20

Sunday Edition Newspaper

Y

First Newspaper Name

Los Angeles Times

First Advertisement Start Date

2021-12-05

Second Newspaper Ad Name

Los Angeles Times

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-12-12

Employer Website From Date

2023-01-01 18:08:50

Employer Website To Date

2023-01-01 18:08:50

Professional Organization Ad From Date

2023-01-01 18:08:50

Professional Organization Advertisement To Date

2023-01-01 18:08:50

Job Search Website From Date

2021-12-07

Job Search Website To Date

2021-12-22

Employee Referral Program From Date

2021-11-18

Employee Referral Program To Date

2021-12-13

Local Ethnic Paper From Date

2021-12-07

Local Ethnic Paper To Date

2021-12-07

Radio/TV Ad From Date

2023-01-01 18:08:50

Radio/TV Ad To Date

2023-01-01 18:08:50

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

TAIWAN

Foreign Worker Birth Country

TAIWAN

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

MANAGEMENT OF DRUG DEVELOPMENT

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LOS ANGELES

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

90007

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Ann H Lee

Preparer Title

Attorney

Preparer Email

ann.lee@ogletree.com

Employer Information Declaration Name

Brenna Murphy

Employer Information Declaration Title

HR Assistant III