Fiscal Year

2023

Case Number

A-22011-96504

Case Status

Certified

Received Date

2022-04-08

Decision Date

2022-12-21

Refile

N

Original File Date

2023-01-01 17:59:20

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

15000

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Caitlin Kelly

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) 250-6338

Employer Contact Email

Caitlin_Kelly@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

P10021268606607

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists ONet 131041.07

PW Skill Level

Level IV

PW Wage

99133.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-03-29

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

Biology, Microbiology, Chemistry, Clinical & Regulatory Affairs 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

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

preparing international product submissions for medical devices

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

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 global regulations relevant to Class II and Class III medical devices. 2. Working with global regulatory requirements for new products or product changes. 3. Medical device development in accordance with design control requirements per applicable regulations. 4. Utilizing PLM platforms to create, review and approve medical device product. 5. Using regulatory platform FDAs eSubmitter, and eCopy requirements, UDI, or eIFU to prepare medical device submissions. 6. Interpreting regulatory requirements for medical devices. 7. Technical writing for regulatory purposes. 8. Supporting and representing the regulatory function including presenting alternatives for meeting regulatory requirements and identifying conflicts between those requirements and development issues for medical products. 9. Working with product development and manufacturing documentation for medical devices protocols, reports, engineering drawings, and procedures to ensure regulatory requirements compliance, consistency, and accuracy; must include reviewing and approving labeling content. 10. Providing guidance on regulatory requirements for strategic and contingency planning. 11. Preparing and overseeing documentation packages for submission to global regulatory agencies. 12. Tracking timelines and documents for inclusion in regulatory submissions. 13. Supporting communications with regulatory agencies as part of submission review and onsite audit support, including CE marking design dossiers and technical files.br br Position requires 5 domestic travel; expenses paid by employer.br br Hiring requirements Drugs 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

2021-11-01

SWA Job Order End Date

2021-12-01

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 17:59:20

Employer Website To Date

2023-01-01 17:59:20

Professional Organization Ad From Date

2023-01-01 17:59:20

Professional Organization Advertisement To Date

2023-01-01 17:59:20

Job Search Website From Date

2021-11-15

Job Search Website To Date

2021-11-21

Employee Referral Program From Date

2023-01-01 17:59:20

Employee Referral Program To Date

2023-01-01 17:59:20

Local Ethnic Paper From Date

2021-11-15

Local Ethnic Paper To Date

2021-11-15

Radio/TV Ad From Date

2023-01-01 17:59:20

Radio/TV Ad To Date

2023-01-01 17:59:20

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 MAJOR CLINICAL REGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

KECK GRADUATE INSTITUTE

Foreign Worker Education Institution Address 1

535 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

Director, Talent Mobility