Fiscal Year

2024

Case Number

A-23108-29374

Case Status

Certified

Received Date

2023-05-15

Decision Date

2024-06-05

Refile

N

Original File Date

2024-01-01 01:36:37

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) 250-6338

Employer Number of Employees

17300

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Lucie Hrnciarova

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) 250-3472

Employer Contact Email

Lucie_Hrnciarova@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

P10022165280266

PW SOC Code

13-1041.07

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

100922.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-12-28

PW Expiration Date

2023-06-30

Wage Offer From

101000.00

Wage Offer To

121328.00

Average Salary

111164.00

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), Engineering* (cont'd in H.14)

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.4B.

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 for medical devices to include any relevant job titles within this occupation

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Contd from H.4B Biomedical, Electrical, Mechanical or a related field.br Contd from H.8 In lieu of Masters degree and 3 years of experience, employer will accept a Bachelors degree or equivalent in Sciences Biology, Microbiology, Chemistry, Regulatory, Engineering Biomedical, Electrical, Mechanical or a related field and 5 years of progressive experience in regulatory affairs for medical devices to include any relevant job titles within this occupation.br br 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 H.12 based on SVP analysis only.br br Work experience to include 1. Working with US and EU regulations that affect Class I, Class II and Class III medical devices. 2. Supporting US Class I, Class II and Class III medical devices and 510k submissions, Letter to Files, and RA Plans. 3. Preparing US submissions for FDA and EU product submissions for EU Notified Bodies. 4. Applying regulatory requirements for new products or product changes as they relate to the regulatory impact of Class I, Class II and Class III medical devices. 5. Supporting product development activities for medical devices. 6. Preparing EU submissions under the MDR regulations. 7. Supporting Canada, Australia, and New Zealand submissions for medical devices. 8. Using Microsoft Office Suite including Word, PowerPoint and Excel to write US and EU regulatory submissions and general office communications related to regulatory compliance. 9. Working in a cross functional team RD, Marketing, and Regulatory Affairs and with regulatory partners on new or sustaining projects. 10. Preparing status updates and presenting regulatory plans to stakeholders from crossfunctional teams, regulatory partners and management for approval. Position requires 10 domestic travel; expenses paid by employer.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

2023-01-24

SWA Job Order End Date

2023-02-24

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2023-03-05

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-03-12

Employer Website From Date

2024-01-01 01:36:37

Employer Website To Date

2024-01-01 01:36:37

Professional Organization Ad From Date

2024-01-01 01:36:37

Professional Organization Advertisement To Date

2024-01-01 01:36:37

Job Search Website From Date

2023-03-06

Job Search Website To Date

2023-03-12

Employee Referral Program From Date

2024-01-01 01:36:37

Employee Referral Program To Date

2024-01-01 01:36:37

Local Ethnic Paper From Date

2023-03-06

Local Ethnic Paper To Date

2023-03-06

Radio/TV Ad From Date

2024-01-01 01:36:37

Radio/TV Ad To Date

2024-01-01 01:36:37

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

BIOMEDICAL ENGINEERING

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

VITERBI SCHOOL OF ENGINEERING

Foreign Worker Education Institution Address 2

300 STUDENT UNION

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

90089

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

Tracie M Pham

Employer Information Declaration Title

Sr. Talent Mobility Specialist