Fiscal Year

2021

Case Number

A-20241-93443

Case Status

Certified

Received Date

2020-10-26

Decision Date

2021-05-12

Refile

N

Original File Date

2021-01-01 09:22:24

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ALIGN TECHNOLOGY, INC.

Employer Name Slug

align-technology-inc

Employer Address 1

2820 ORCHARD PARKWAY

Employer Address 2

Employer City

SAN JOSE

Employer City Slug

san-jose

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

95134

Employer Phone

(408) 470-1420

Employer Number of Employees

12292

Employer Year Commenced Business

1997

NAICS Code

33911

FW Ownership Interest

N

Employer Contact Name

Colleen Chelli

Employer Contact Address 1

2820 Orchard Parkway

Employer Contact Address 2

Employer Contact City

San Jose

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

95134

Employer Contact Phone

(408) 470-1420

Employer Contact Email

cchelli@aligntech.com

Agent Attorney Name

Christopher J Fleischut

Agent Attorney Firm Name

Naya Law Group PC dba Finnan, Fleischut Associates

Agent Attorney Phone

650.499.5187

Agent Attorney Address 1

2025 Gateway Place

Agent Attorney Address 2

Suite 220

Agent Attorney City

San Jose

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

95110

Agent Attorney Email

ffamail@fleischut.com

PW Track Number

P10020042314549

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

111363.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-05-01

PW Expiration Date

2020-07-30

Wage Offer From

125000.00

Wage Offer To

180000.00

Average Salary

152500.00

Wage Unit of Pay

Year

Worksite Address 1

2820 Orchard Parkway

Worksite Address 2

Worksite City

San Jose

Worksite City Slug

san-jose

Worksite State

CALIFORNIA

Worksite Postal Code

95134

Job Title

Regulatory Engineering Manager

Job Title Slug

regulatory-engineering-manager

Minimum Education

Bachelor's

Major Field of Study

Regulatory Affairs, Engineering or Biological Science

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Regulatory Affairs, Engineering or Biological Science

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

60

Accept Alternative Job Title

experience in a regulatory affairs compliance capacity

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Understanding of technical design concepts for medical devices derived from hardware and software components. Working knowledge of medical device regulatory compliance frameworks including Quality System regulations for medical devices 21 CFR 820, ISO 13485, ISO 14971. Track record of successful experience authoring software andor hardware Medical Device regulatory submissions approved by external regulatory agencies. Experience guiding design teams in defining appropriate regulatory strategies for software and hardwarederived medical devices.

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

2020-07-17

SWA Job Order End Date

2020-08-24

Sunday Edition Newspaper

Y

First Newspaper Name

The Mercury News

First Advertisement Start Date

2020-07-19

Second Newspaper Ad Name

The Mercury News

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-07-26

Employer Website From Date

2020-07-15

Employer Website To Date

2020-08-21

Professional Organization Ad From Date

2021-01-01 09:22:24

Professional Organization Advertisement To Date

2021-01-01 09:22:24

Job Search Website From Date

2020-07-19

Job Search Website To Date

2020-08-18

Employee Referral Program From Date

2020-07-15

Employee Referral Program To Date

2020-08-21

Local Ethnic Paper From Date

2021-01-01 09:22:24

Local Ethnic Paper To Date

2021-01-01 09:22:24

Radio/TV Ad From Date

2021-01-01 09:22:24

Radio/TV Ad To Date

2021-01-01 09:22:24

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

INDUSTRIAL SYSTEMS ENGINEERING

Foreign Worker Years of Education Completed

2006

Foreign Worker Institution of Education

NORTHERN ILLINOIS UNIVERSITY

Foreign Worker Education Institution Address 1

1425 LINCOLN HWY,

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

DEKALB

Foreign Worker Education Institution State/Province

IL

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

60115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Shama Merchant

Preparer Title

attorney

Preparer Email

ffamail@fleischut.com

Employer Information Declaration Name

Michael Brittain

Employer Information Declaration Title

Sr Talent Acquisition Partner