Fiscal Year

2022

Case Number

A-21189-14093

Case Status

Certified

Received Date

2022-01-27

Decision Date

2022-09-27

Refile

N

Original File Date

2022-01-01 06:40:52

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

EDWARDS LIFESCIENCES LLC

Employer Name Slug

edwards-lifesciences-llc

Employer Address 1

ONE EDWARDS WAY

Employer Address 2

Employer City

IRVINE

Employer City Slug

irvine

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92614

Employer Phone

(949) 250-3444

Employer Number of Employees

15000

Employer Year Commenced Business

2000

NAICS Code

33911

FW Ownership Interest

N

Employer Contact Name

Tracie Pham

Employer Contact Address 1

ONE EDWARDS WAY

Employer Contact Address 2

Employer Contact City

IRVINE

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92614

Employer Contact Phone

(949) 250-3444

Employer Contact Email

Tracie_Pham@edwards.com

Agent Attorney Name

Diana V Coker

Agent Attorney Firm Name

Larrabee Albi Coker LLP

Agent Attorney Phone

(858) 642-0420

Agent Attorney Address 1

P.O. Box 919016

Agent Attorney Address 2

Agent Attorney City

San Diego

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92191-9016

Agent Attorney Email

diana@larrabee.com

PW Track Number

P10021118266675

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists SOC 131041.07

PW Skill Level

Level III

PW Wage

81702.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-10-05

PW Expiration Date

2022-06-30

Wage Offer From

99133.00

Wage Offer To

0.00

Average Salary

99133.00

Wage Unit of Pay

Year

Worksite Address 1

One Edwards Way

Worksite Address 2

Worksite City

Irvine

Worksite City Slug

irvine

Worksite State

CALIFORNIA

Worksite Postal Code

92614

Job Title

Sr. Specialist, Regulatory Affairs

Job Title Slug

sr-specialist-regulatory-affairs

Minimum Education

Master's

Major Field of Study

sciences (Biology, Microbiology, Chemistry, Regulatory) or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

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

preparing domestic international product submissions for medical devices

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Contd from H.12 Job requirements are normal for the employer due to the complexity of job duties associated with this position. Employer answered no to Question H12 based on SVP analysis only.br br Contd from H.8AC In lieu of Masters degree and 3 years of experience, employer will accept a Bachelors degree or equivalent in sciences Biology, Microbiology, Chemistry, Regulatory or a related field and 5 years of progressive experience preparing domestic and international product submissions for medical devices.br br Work experience to include 1. Working with OUS regulations to include any countries except U.S., Europe and Canada relevant to Class II andor Class III medical devices. 2. Working with OUS to include any countries except U.S., Europe and Canada regulatory requirements for new medical products or product changes. 3. Supporting new medical product development systems to meet OUS regulatory submission and compliance requirements. 4. Using Microsoft Office Suite including Word, PowerPoint and Excel to write OUS regulatory submissions and general office communications related to regulatory compliance. 5. Working in a cross functional team RD, Marketing, and Regulatory Affairs and with OUS regulatory partners on new andor sustaining projects. 6. Preparing status updates and presenting OUS regulatory plans to stakeholders from crossfunctional teams, regulatory partners and management for approval. Academic coursework to include 7. Clinical and regulatory affairs.br Hiring Requirements Drug TestingScreening, Background Checks.

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

2021-08-20

SWA Job Order End Date

2021-09-21

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2021-09-19

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-09-26

Employer Website From Date

2022-01-01 06:40:52

Employer Website To Date

2022-01-01 06:40:52

Professional Organization Ad From Date

2022-01-01 06:40:52

Professional Organization Advertisement To Date

2022-01-01 06:40:52

Job Search Website From Date

2021-09-20

Job Search Website To Date

2021-10-01

Employee Referral Program From Date

2022-01-01 06:40:52

Employee Referral Program To Date

2022-01-01 06:40:52

Local Ethnic Paper From Date

2021-09-20

Local Ethnic Paper To Date

2021-09-20

Radio/TV Ad From Date

2022-01-01 06:40:52

Radio/TV Ad To Date

2022-01-01 06:40:52

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

BIOSCIENCE CLINICAL REGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

KECK GRADUATE INSTITUTE

Foreign Worker Education Institution Address 1

533 WATSON DRIVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CLAREMONT

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

91711

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Diana V Coker

Preparer Title

PartnerAttorney at Law

Preparer Email

Diana@larrabee.com

Employer Information Declaration Name

Heather Sheira

Employer Information Declaration Title

Sr. Manager, Global Mobility