Fiscal Year

2021

Case Number

A-20113-45989

Case Status

Certified-Expired

Received Date

2020-05-26

Decision Date

2020-11-18

Refile

N

Original File Date

2021-01-01 08:51:25

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ALPHATEC SPINE INC.

Employer Name Slug

alphatec-spine-inc

Employer Address 1

1950 CAMINO VIDA ROBLE

Employer Address 2

Employer City

CARLSBAD

Employer City Slug

carlsbad

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92008

Employer Phone

760-431-9286

Employer Number of Employees

243

Employer Year Commenced Business

1990

NAICS Code

339113

FW Ownership Interest

N

Employer Contact Name

Emily Beach

Employer Contact Address 1

5818 El Camino Real

Employer Contact Address 2

Employer Contact City

Carlsbad

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92008

Employer Contact Phone

760-494-6807

Employer Contact Email

ebeach@atecspine.com

Agent Attorney Name

William L Coffman

Agent Attorney Firm Name

Mintz Levin Cohn Ferris Glovsky and Popeo PC

Agent Attorney Phone

617.348.1890

Agent Attorney Address 1

Mintz Levin Cohn Ferris Glovsky and Popeo PC

Agent Attorney Address 2

One Financial Center, 40th Floor

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2111

Agent Attorney Email

wlcoffman@mintz.com

PW Track Number

P10019330167649

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

93392.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-03-18

PW Expiration Date

2020-06-30

Wage Offer From

93392.00

Wage Offer To

0.00

Average Salary

93392.00

Wage Unit of Pay

Year

Worksite Address 1

5818 El Camino Real

Worksite Address 2

Worksite City

Carlsbad

Worksite City Slug

carlsbad

Worksite State

CALIFORNIA

Worksite Postal Code

92008

Job Title

Regulatory Affairs Specialist

Job Title Slug

regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Medicine, Pre-Med, Management of Drug Dvlpmnt, or related (see H.14 for details)

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

Any occupation that meets requirements in H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

All requirements A Masters degree or foreign equivalent in Medicine, PreMed, Management of Drug Development, or a related life sciences discipline with an emphasis in the regulation of pharmaceutical and biological products followed by 2 years of experience in a regulatory affairs specialistrelated occupation.br br In the alternative, the employer will accept a Bachelors degree or foreign equivalent in Medicine, PreMed, Management of Drug Development, or a related life sciences discipline with an emphasis in the regulation of pharmaceutical and biological products followed by 5 years of postbaccalaureate experience in a regulatory affairs specialistrelated occupation.br br Experience must include the following, which may have been gained concurrentlybr br 1 2 years of experience using FDA Quality System Requirements QSR, ISO 13485, or MDD 9342EEC;br 2 2 years of experience with Standard Operation Procedures SOP and Work Instruction WI writing;br 3 1 year of Quality System auditing experience;br 4 1 year of experience with FDA regulations for medical devices, including FDA 510k submission experience for spine products;br 5 1 year of experience with clinical knowledge in spine anatomy, spine surgical procedures and spine products;br 6 Regulatory Affairs Certification RAC from Regulatory Affairs Certification Board;br 7 Certificate of Completion for QMS Lead Auditor Course to include ISO 134852016.

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

2020-03-20

SWA Job Order End Date

2020-04-22

Sunday Edition Newspaper

Y

First Newspaper Name

San Diego UnionTribune

First Advertisement Start Date

2020-03-29

Second Newspaper Ad Name

San Diego UnionTribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-04-05

Employer Website From Date

2021-01-01 08:51:25

Employer Website To Date

2021-01-01 08:51:25

Professional Organization Ad From Date

2021-01-01 08:51:25

Professional Organization Advertisement To Date

2021-01-01 08:51:25

Job Search Website From Date

2020-03-19

Job Search Website To Date

2020-04-02

Employee Referral Program From Date

2021-01-01 08:51:25

Employee Referral Program To Date

2021-01-01 08:51:25

Local Ethnic Paper From Date

2020-04-02

Local Ethnic Paper To Date

2020-04-02

Radio/TV Ad From Date

2020-04-08

Radio/TV Ad To Date

2020-04-08

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CHINA

Foreign Worker Birth Country

CHINA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

MANAGEMENT OF DRUG DEVELOPMENT

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

777785 WEST JEFFERSON BLVD.

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

90007

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

William L Coffman

Preparer Title

Attorney

Preparer Email

wlcoffman@mintz.com

Employer Information Declaration Name

Emily Beach

Employer Information Declaration Title

Manager, People Culture