Fiscal Year

2024

Case Number

A-22293-43464

Case Status

Certified-Expired

Received Date

2022-11-22

Decision Date

2023-10-10

Refile

N

Original File Date

2024-01-01 00:03:32

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

33911

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

P10022097045299

PW SOC Code

11-9199.01

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

188323.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-10-20

PW Expiration Date

2023-06-30

Wage Offer From

188323.00

Wage Offer To

0.00

Average Salary

188323.00

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. Manager, Regulatory Affairs, Transcatheter Heart Valve

Job Title Slug

sr-manager-regulatory-affairs-transcatheter-heart-valve

Minimum Education

Master's

Major Field of Study

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

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

10

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

96

Accept Alternative Job Title

regulatory affairs within the medical device industry

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

In H.8A through H.8C In lieu of a Masters degree and 8 years of experience employer will accept a Bachelors degree or equivalent in Regulatory Affairs, sciences Biology, Microbiology, Chemistry, or a related field and 10 years of progressive experience in regulatory affairs within the medical device industry.br br 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 European regulations relevant to Class II or Class III medical devices. 2. Working with global regulatory requirements for new medical products or product changes. 3. Providing review and input of protocols and reports for design verification, design validation, process qualifications, biocompatibility studies, shelf life, preclinical studies, and clinical studies. 4. Writing and submitting technical documents including 510ks, IDEs, PMAs, CE design dossiertechnical files and clinical trial protocols and updates utilizing productrelated technical documentation preclinical, clinical, manufacturing and quality reports and procedures. 5. Reviewing design change control documents, validation reports, and post market product surveillance reports. 6. Working in crossfunctional project teams as a representative of the regulatory affairs function. 7. Determining regulatory paths for new product development and product and process changes. 8. Preparing status updates and written reports and presenting arguments for regulatory plans to stakeholders from crossfunctional teams and management for approval. 9. Evaluating new medical product development projects across at least 2 product portfolios simultaneously to identify the relationships and points of leverage. 10. Utilizing business management computer systems. 11. Consulting experience in project setting within cardiovascular devices.br br Hiring Requirements Drug TestingScreening, Background Check.

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

2022-08-26

SWA Job Order End Date

2022-09-26

Sunday Edition Newspaper

Y

First Newspaper Name

The Orange County Register

First Advertisement Start Date

2022-09-11

Second Newspaper Ad Name

The Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-09-18

Employer Website From Date

2024-01-01 00:03:32

Employer Website To Date

2024-01-01 00:03:32

Professional Organization Ad From Date

2024-01-01 00:03:32

Professional Organization Advertisement To Date

2024-01-01 00:03:32

Job Search Website From Date

2022-09-12

Job Search Website To Date

2022-09-18

Employee Referral Program From Date

2024-01-01 00:03:32

Employee Referral Program To Date

2024-01-01 00:03:32

Local Ethnic Paper From Date

2022-09-12

Local Ethnic Paper To Date

2022-09-12

Radio/TV Ad From Date

2024-01-01 00:03:32

Radio/TV Ad To Date

2024-01-01 00:03:32

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 AFFAIRS

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

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

Partner Attorney at Law

Preparer Email

Diana@larrabee.com

Employer Information Declaration Name

Tracie M Pham

Employer Information Declaration Title

Senior Talent Mobility Specialist