Fiscal Year

2021

Case Number

A-20140-56322

Case Status

Certified-Expired

Received Date

2020-08-10

Decision Date

2021-03-23

Refile

N

Original File Date

2021-01-01 09:08:09

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

14000

Employer Year Commenced Business

2000

NAICS Code

339112

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

Claudia P Martorell

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

claudia@larrabee.com

PW Track Number

P10020059360528

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists OES 131041.07

PW Skill Level

Level III

PW Wage

82722.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-05-14

PW Expiration Date

2020-08-12

Wage Offer From

100000.00

Wage Offer To

0.00

Average Salary

100000.00

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, Chemistry or Regulatory), * (cont'd in H.14)

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

regulatory affairs experience within the medical device andor pharmaceutical industry

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Contd. from H.4B engineering Biomedical, Electrical or Mechanical or a related field.br br In H.8AC Employer requires progressive experience in regulatory affairs within the medical device andor pharmaceutical industry.br br Work experience to includebr 1. Three years of medical device regulatory experience including 510 k submissions and EU Technical Files and Dossiers for CE Marking. 2. Submission experience with Class II or Class III medical devices, including experience with monitoring devices. 3. Regulatory experience preparing U.S., EU, Canada, Australia and New Zealand medical product submissions. 4. Applying the regulatory requirements for new products or product changes related to labeling and advertising of Class II or Class III medical devices. 5. Supporting new medical product development systems. 6. Working with U.S. and EU regulations that affect Class II or Class III medical devices. 7. Working in cross functional team RD, Quality, Manufacturing, Marketing, Clinical, and Regulatory Affairs for new or existing medical device development projects. 8. Preparing status updates and written reports and presenting arguments for regulatory plans to stakeholders from crossfunctional teams and management for approval.br 9. Evaluating new medical product development projects across multiple product portfolios to identify the relationships and points of leverage. 10. Using Microsoft Word, Power Point and Excel to write analytical reports, policies and procedures, and general office communications related to regulatory compliance. 11. Operating a business management computer system. 12. Writing U.S. Class II or Class III and Outsidethe U.S. OUS regulatory submissions from productrelated technical documentation preclinical, clinical, manufacturing and quality reports and procedures. 13. Reviewing and signing medical product design and change documentation, test protocols and reports, product labeling and procedures documentation. 14. Preparing and executing a communication strategy to functional business partners regarding changes to regulatory requirements. 15. Participating in risk mitigation and control measure activities for medical devices. 16. Reviewing design change control documents, product recall documentation, validation reports, and post market product surveillance reports. Any and all experience can be gained concurrently.br Hiring Requirements Drug TestingScreening and 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

2020-03-06

SWA Job Order End Date

2020-04-06

Sunday Edition Newspaper

Y

First Newspaper Name

The Orange County Register

First Advertisement Start Date

2020-03-22

Second Newspaper Ad Name

The Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-03-29

Employer Website From Date

2021-01-01 09:08:09

Employer Website To Date

2021-01-01 09:08:09

Professional Organization Ad From Date

2021-01-01 09:08:09

Professional Organization Advertisement To Date

2021-01-01 09:08:09

Job Search Website From Date

2020-03-23

Job Search Website To Date

2020-03-27

Employee Referral Program From Date

2021-01-01 09:08:09

Employee Referral Program To Date

2021-01-01 09:08:09

Local Ethnic Paper From Date

2020-03-23

Local Ethnic Paper To Date

2020-03-23

Radio/TV Ad From Date

2021-01-01 09:08:09

Radio/TV Ad To Date

2021-01-01 09:08:09

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

REGULATORY SCIENCE

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

UNIVERSITY PARK CAMPUS

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

Claudia P Martorell

Preparer Title

PartnerAttorney at Law

Preparer Email

claudia@larrabee.com

Employer Information Declaration Name

Heather Sheira

Employer Information Declaration Title

Sr. Manager, Global Mobility