INTUITIVE SURGICAL OPERATIONS, INC

Regulatory Affairs Specialist

A-22237-11929 H-1B 2023 Certified

Salary

$76,773

Visa Type

H-1B

Job Title

Regulatory Affairs Specialist

Employee's Citizenship

INDIA

Graduate School

ST. CLOUD STATE UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22237-11929

Case Status Certified

Received Date 2022-09-01

Decision Date 2023-07-10

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 INTUITIVE SURGICAL OPERATIONS, INC

Employer Address_Line 1 1020 KIFER ROAD

Employer Address_Line 2 -

Employer City SUNNYVALE

State -

Employer State/ Province CALIFORNIA

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 94086

Employer Phone No. 4085232100

Employer Phone Extent No. -

Total Number of Employees 7160

Employer Year of Commenced 2009

NAICS Code 33911

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Hien Nguyen

Employer Contact Address Line1 1020 Kifer Road

Employer Contact Address Line2 -

Employer Contact City Sunnyvale

Employer Contact State/ Provice CALIFORNIA

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 94086

Employer Contact Phone 408-523-7070

Employer Contact Email hien.nguyen@intusurg.com

Attorney

11 fields

Agent/ Attorney Name Sonal Kinger

Agent/ Attorney Firm Name Graham Adair, Inc.

Agent/ Attorney Phone 408-213-5092

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 502 W. 30th Street

Agent/ Attorney Address Line 2 -

Agent/ Attorney City Austin

Agent/ Attorney State/ Province TEXAS

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code 78705

Agent/ Attorney Email skinger@grahamadair.com

Position Info

89 fields

Prevailing Wage Track Number P10021306682686

Prevailing Wage SOC Code 13-1041

Prevailing Wage SOC Title Regulatory Affairs Specialists

Prevailing Wage Skill Level Level II

Prevailing Wage 76773

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-05-09

Prevailing Wage Expiration Date 2022-08-07

Wage Offer From 98000

Wage Offer To 141000

Wage Offer Unit of Pay Year

Workstie Address Line 1 1020 Kifer Road

Worksite Address Line 2 -

Worksite City Sunnyvale

Worksite State CALIFORNIA

Worksite Postal Code 94086

Job Title Regulatory Affairs Specialist

Minimum Education Master's

Other Degree/ Diploma -

Major Field of Study Regulatory Affairs and Services or related

Required Training N

Required Training Month -

Required Field of Training -

Required Experience Y

Required Expreience Months 12

Accept Alternate Field of Study Y

Accept Alternate Major Regulatory Affairs and Services or related

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 12

Accept Alternate Job Title Regu Affairs Spect RAS, Regu Affairs Intern, Regu Affairs Coop Intern, Sr Biomedical Engr or rltd

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Masters degree or foreign equivalent in Regulatory Affairs and Services or related plus 1 year experience. At least 1 year of experience with the following Creating Technical Files under MDR framework; Write and gain FDA review of different types of Class II medical devices submissions; Write and gain FDA review of Presubmission; Verification and Validation plans and strategies for new products and enhancements.

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 2022-05-10

Job Oder End Date 2022-06-10

Sunday Edition Newspaper Y

First Newspaper Name The Mercury News Bay Area News Group

First Advertisement Start Date 2022-05-15

Second Newspaper Name The Mercury News Bay Area News Group

Second Advertisement Type Newspaper

Second Ad Start Date 2022-05-22

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date -

Employer Website to Date -

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-05-13

Job Search Website to Date 2022-05-26

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date 2022-05-13

Employee Referral Program to Date 2022-06-14

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-05-18

Local Ethnic Newspaper to Date 2022-05-24

Radio/TV Ad from Date -

Radio/TV Ad to Date -

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 REGULATORY AFFAIRS SERVICES

Year of Compelted Education 2019

Foreign Worker Istitution of Eduation ST. CLOUD STATE UNIVERSITY

Foreign Worker Education Instution Address Line 1 9750 ROCKFORD RD

Foreign Worker Education Institution Address Line 2 STE. 100

Foreign Worker Education Institution City PLYMOUTH

Foreign Worker Educatution Institution State MN

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 55442

Foreign Worker Training Completion N/A

Foreign Worker Required Experience Y

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name Sonal Kinger

Preparer Title Attorney

Preparer Email skinger@grahamadair.com

Employer Information Declaration Name Katie Brackett

Employer Declaration Title Global Mobility Specialist