Fiscal Year

2024

Case Number

A-22306-50558

Case Status

Certified-Expired

Received Date

2022-11-07

Decision Date

2024-01-18

Refile

N

Original File Date

2024-01-01 00:35:19

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Zap Surgical Systems, Inc.

Employer Name Slug

zap-surgical-systems-inc

Employer Address 1

590 TAYLOR WAY STE A

Employer Address 2

Employer City

SAN CARLOS

Employer City Slug

san-carlos

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

94070

Employer Phone

9255705316

Employer Number of Employees

95

Employer Year Commenced Business

2014

NAICS Code

334517

FW Ownership Interest

N

Employer Contact Name

Robert Starr

Employer Contact Address 1

590 Taylor Way

Employer Contact Address 2

Ste. A

Employer Contact City

San Carlos

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

94070

Employer Contact Phone

6504927797

Employer Contact Email

bob@zapsurgical.com

Agent Attorney Name

Danielle Gotcher

Agent Attorney Firm Name

Global Immigration Partners, Inc

Agent Attorney Phone

818-914-6482

Agent Attorney Address 1

30300 Agoura Road

Agent Attorney Address 2

Ste B100

Agent Attorney City

Agoura Hills

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

91301

Agent Attorney Email

perm@gip-us.com

PW Track Number

P10022019838597

PW SOC Code

11-9199.01

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level II

PW Wage

143562.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-08-10

PW Expiration Date

2023-06-30

Wage Offer From

145000.00

Wage Offer To

150000.00

Average Salary

147500.00

Wage Unit of Pay

Year

Worksite Address 1

590 Taylor Way

Worksite Address 2

Ste. A

Worksite City

San Carlos

Worksite City Slug

san-carlos

Worksite State

CALIFORNIA

Worksite Postal Code

94070

Job Title

Regulatory Affairs Manager

Job Title Slug

regulatory-affairs-manager

Minimum Education

Master's

Major Field of Study

See H.14

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See. H.14

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

24

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Masters degree in Biomedical Engineering, Diagnostic Engineering, Medical Science, Regulatory Affairs or Regulatory Science, Medical Technology, or any related field of study, plus at least two 2 years of experience in the job offered or in any related positions.br br Qualified candidates must also have demonstrable knowledge, experience, skill, and proficiency gained through education or employment with the followingbr br 1.Demonstrated experience in the medical device industry.br 2.Demonstrated experience with Good Clinical Practices, Good Manufacturing Practices and FDA regulations.br 3.Demonstrated experience with Quality System Regulations and ISO 134852016 or ISO 14971.br 4.Demonstrated experience with EU MDR or EU MDD requirements.br 5.Demonstrated experience developing regulatory strategies and implemented plans for the preparation and submission of regulatory filings for manufactured products.br 6.Demonstrated experience implementing organizational and policy changes related to regulatory matters.br 7.Demonstrated experience managing regulatory activities such as audits, agency inspections, or product recalls.br 8.Demonstrated ability and experience handling multiple projects simultaneously and prioritizing work to meet reporting and other deadlines.br br No travel required. Work from home benefit available.

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

2022-08-20

SWA Job Order End Date

2022-09-23

Sunday Edition Newspaper

Y

First Newspaper Name

The Mercury News and the East Bay Times

First Advertisement Start Date

2022-08-28

Second Newspaper Ad Name

The Mercury News and the East Bay Times

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-09-04

Employer Website From Date

2024-01-01 00:35:19

Employer Website To Date

2024-01-01 00:35:19

Professional Organization Ad From Date

2024-01-01 00:35:19

Professional Organization Advertisement To Date

2024-01-01 00:35:19

Job Search Website From Date

2022-08-20

Job Search Website To Date

2022-09-03

Employee Referral Program From Date

2022-08-23

Employee Referral Program To Date

2022-09-30

Local Ethnic Paper From Date

2022-09-02

Local Ethnic Paper To Date

2022-09-09

Radio/TV Ad From Date

2024-01-01 00:35:19

Radio/TV Ad To Date

2024-01-01 00:35:19

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

MEDICAL DEVICE AND DIAGNOSTIC ENGINEERING

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

UNIVERSITY PARK

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LOS ANGELES

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

90089

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Danielle Gotcher

Preparer Title

Attorney

Preparer Email

perm@gip-us.com

Employer Information Declaration Name

Robert A Starr

Employer Information Declaration Title

Vice President, HR