Fiscal Year

2023

Case Number

A-21313-70663

Case Status

Certified

Received Date

2022-04-29

Decision Date

2023-01-09

Refile

N

Original File Date

2023-01-01 08:16:35

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

16000

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Tracie M 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

P10021169409310

PW SOC Code

13-1041

PW SOC Title

OES 131041.07 Regulatory Affairs Specialists

PW Skill Level

PW Wage

128917.00

PW Unit of Pay

Year

PW Wage Source

Other

PW Determination Date

2022-01-25

PW Expiration Date

2022-06-30

Wage Offer From

129000.00

Wage Offer To

139000.00

Average Salary

134000.00

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

Associate Manager, Regulatory Affairs

Job Title Slug

associate-manager-regulatory-affairs

Minimum Education

Master's

Major Field of Study

sciences (Biology, Pharmacy), Regulatory Affairs* (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

8

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

72

Accept Alternative Job Title

regulatory affairs within the medical device industry

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Contd from H.4B engineering Chemical, Biomedical or a related field.br br In H.8.A through C in lieu of a Masters degree and 6 years of experience employer will accept a Bachelors degree or equivalent in sciences Biology, Pharmacy, Regulatory Affairs, engineering Chemical, Biomedical or a related field and 8 years of progressive experience in regulatory affairs within the medical device industry.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 H12 based on SVP analysis only.br br br Work experience to include 1. Six years of experience preparing domestic or international medical product submissions to regulatory agencies. 2. Six years of experience working with Chinese regulations that affect Class II or Class III medical devices, applying these regulationsregulatory requirements to obtain approvals for new medical products or changes to existing products or processes. 3. Working with data generated by new product development systems to demonstrate safety and efficacy compliance of Class II or Class III medical devices. 4. Providing regulatory agencies and international regulatory partners with supporting documentation and information for regulatory submissions that demonstrate safety and efficacy of the medical device, including deficiency letters responses and documentation addressing risk mitigation and control measure activities. 5. Coordinating with Subject Matter Experts from crossfunctional groups RD, Clinical, and Manufacturing to address testing and documentation requirements unique to Rest of World globe minus US, EU and Canada markets. 6. Reviewing and approving medical device design and change documentation, test protocols, reports, and product labeling and procedures documents to ensure accuracy and completeness. 7. Supporting the investigation of nonconformance issues and execution of action plans in compliance with respective quality system regulations and standards to include 21 CFR 820 and ISO 13485. Any and all experience can be gained concurrently.br 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

2022-01-25

SWA Job Order End Date

2022-02-25

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2021-11-14

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-11-21

Employer Website From Date

2023-01-01 08:16:35

Employer Website To Date

2023-01-01 08:16:35

Professional Organization Ad From Date

2023-01-01 08:16:35

Professional Organization Advertisement To Date

2023-01-01 08:16:35

Job Search Website From Date

2021-11-15

Job Search Website To Date

2021-11-21

Employee Referral Program From Date

2023-01-01 08:16:35

Employee Referral Program To Date

2023-01-01 08:16:35

Local Ethnic Paper From Date

2021-11-15

Local Ethnic Paper To Date

2021-11-15

Radio/TV Ad From Date

2023-01-01 08:16:35

Radio/TV Ad To Date

2023-01-01 08:16:35

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CHINA

Foreign Worker Birth Country

CHINA

Class of Admission

L-1

Foreign Worker Education

Master's

Foreign Worker Information: Major

TRADITIONAL CHINESE PHARMA EQUIV. TO US MS IN PHARMACEUTICAL SCIENCE

Foreign Worker Years of Education Completed

2010

Foreign Worker Institution of Education

HARBIN UNIVERSITY OF COMMERCE

Foreign Worker Education Institution Address 1

NO.1 XUEHAI AVE SONGBEI DISTRICT

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

HARBIN

Foreign Worker Education Institution State/Province

HEILONGJIANG

Foreign Worker Education Institution Country

CHINA

Foreign Worker Education Institution Postal Code

150028

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