MASIMO CORPORATION

Regulatory Specialist II

A-22265-26902 H-1B 2023 Certified

Salary

$68,266

Visa Type

H-1B

Job Title

Regulatory Specialist II

Employee's Citizenship

INDIA

Graduate School

UNIVERSITY OF SOUTHERN CALIFORNIA

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22265-26902

Case Status Certified

Received Date 2022-09-23

Decision Date 2023-07-31

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name MASIMO CORPORATION

Employer Address_Line 1 52 DISCOVERY

Employer Address_Line 2 -

Employer City IRVINE

State -

Employer State/ Province CALIFORNIA

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 92618

Employer Phone No. 949-297-7419

Employer Phone Extent No. -

Total Number of Employees 1300

Employer Year of Commenced 1989

NAICS Code 334510

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Delora Sandoval

Employer Contact Address Line1 52 DISCOVERY

Employer Contact Address Line2 -

Employer Contact City Irvine

Employer Contact State/ Provice CALIFORNIA

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 92618

Employer Contact Phone 949-297-7419

Employer Contact Email dsandoval@masimo.com

Attorney

11 fields

Agent/ Attorney Name Blake G Miller

Agent/ Attorney Firm Name Fragomen, Del Rey, Bernsen Loewy LLP

Agent/ Attorney Phone 9498629492

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 18401 Von Karman Ave.

Agent/ Attorney Address Line 2 Ste. 255

Agent/ Attorney City Irvine

Agent/ Attorney State/ Province CALIFORNIA

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code 92612

Agent/ Attorney Email bmiller@fragomen.com

Position Info

89 fields

Prevailing Wage Track Number P10021267604935

Prevailing Wage SOC Code 13-1041

Prevailing Wage SOC Title Regulatory Affairs Specialists

Prevailing Wage Skill Level Level II

Prevailing Wage 68266

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-03-25

Prevailing Wage Expiration Date 2022-06-30

Wage Offer From 82000

Wage Offer To 85000

Wage Offer Unit of Pay Year

Workstie Address Line 1 Masimo Corporation

Worksite Address Line 2 -

Worksite City 15750 Alton Pkwy

Worksite State CALIFORNIA

Worksite Postal Code 92618

Job Title Regulatory Specialist II

Minimum Education Bachelor's

Other Degree/ Diploma -

Major Field of Study Biomedical Engineering, Regulatory, Chemistry, Biology, Quality Management

Required Training N

Required Training Month -

Required Field of Training -

Required Experience Y

Required Expreience Months 24

Accept Alternate Field of Study Y

Accept Alternate Major Closely related field

Alternate Combination of Education/ Experience Y

Required Alternate Level of Education Master's

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 24

Accept Alternate Job Title Job offered or closely related occupatin

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Must possess expertiseknowledge sufficient to adequately perform the duties of the job being offered. Expertiseknowledge may be gained through employment experience or education. Such expertiseknowledge cannot be quantified by time. Required expertiseknowledge includes Previous experience in a medical device Class II III environment; Experience in patient monitor systems, hospitalbased products, software or electronic device products ; Knowledge of regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission; Experience with FDAGMP requirements for medical device; Experience in Quality Systems, per ISO 13485; Knowledge of biostatistics and statistics for clinical studies; and Knowledge of human anatomy and physiology.br br Employer will accept a Bachelors degree or foreign equivalent in Biomedical Engineering, Regulatory, Chemistry, Biology, Quality management or closely related field plus 2 two years of experience in the job offered or closely related occupation OR a Masters degree or foreign equivalent in Biomedical Engineering, Regulatory, Chemistry, Biology, Quality management or closely related field

Combination Occupation N

Offered to Applied Foreign Worker Y

ForeignWorker Live on Premises N

Live in Domestic Service Worker N

Employment Contract -

Professional Occupation Y

College/ University Teacher N

Competitive Process -

Basic Recruitment Process -

Teacher Select Date -

Teacher Publish Journal Name -

Additional Recruitment Information -

Job Oder Start Date 2022-03-28

Job Oder End Date 2022-04-29

Sunday Edition Newspaper Y

First Newspaper Name Los Angeles Times

First Advertisement Start Date 2022-05-08

Second Newspaper Name Los Angeles Times

Second Advertisement Type Newspaper

Second Ad Start Date 2022-05-15

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2022-05-02

Employer Website to Date 2022-05-10

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date -

Job Search Website to Date -

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date 2022-05-02

Employee Referral Program to Date 2022-05-16

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date -

Local Ethnic Newspaper to Date -

Radio/TV Ad from Date 2022-05-14

Radio/TV Ad to Date 2022-05-14

Employer Received the Payment N

Payment Details -

Bargaining Representative Notified N/A

Posted Notice at Worksite Y

Layoff in Past Six Months N

US Worker Considered -

Country of Citizenship INDIA

Foreign Worker Birth Country INDIA

Class of Admission H-1B

Employee Info

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major BIOMEDICAL ENGINEERING

Year of Compelted Education 2020

Foreign Worker Istitution of Eduation UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Instution Address Line 1 UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City LOS ANGELES

Foreign Worker Educatution Institution State CA

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 90007

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N

Foreign Worker Alternate Education and Experience Y

Foreign Worker Alternate Occupation Experience N

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name Blake Miller

Preparer Title Partner

Preparer Email bmiller@fragomen.com

Employer Information Declaration Name Delora Sandoval

Employer Declaration Title HR Compliance Immigration Manager