Fiscal Year

2020

Case Number

A-19214-39505

Case Status

Withdrawn

Received Date

2019-09-27

Decision Date

2019-12-04

Refile

N

Original File Date

2020-01-01 07:46:41

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

DEXCOM, INC.

Employer Name Slug

dexcom-inc

Employer Address 1

6340 SEQUENCE DRIVE

Employer Address 2

Employer City

SAN DIEGO

Employer City Slug

san-diego

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92121

Employer Phone

(858) 875-9520

Employer Number of Employees

2609

Employer Year Commenced Business

1999

NAICS Code

334510

FW Ownership Interest

N

Employer Contact Name

Brandee Spath

Employer Contact Address 1

6310 Sequence Drive

Employer Contact Address 2

Employer Contact City

San Diego

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92121

Employer Contact Phone

(858) 875-9885

Employer Contact Email

[email protected]

Agent Attorney Name

Amanda M Mullane

Agent Attorney Firm Name

Larrabee Albi Coker LLP

Agent Attorney Phone

858-642-0420

Agent Attorney Address 1

Larrabee Albi Coker LLP

Agent Attorney Address 2

P.O. Box 919016

Agent Attorney City

San Diego

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92191-9016

Agent Attorney Email

[email protected]

PW Track Number

P10019029124010

PW SOC Code

13-1041

PW SOC Title

131041.07 Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

94474.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-05-16

PW Expiration Date

2019-08-14

Wage Offer From

94474.00

Wage Offer To

0.00

Average Salary

94474.00

Wage Unit of Pay

Year

Worksite Address 1

6310 Sequence Drive

Worksite Address 2

Worksite City

San Diego

Worksite City Slug

san-diego

Worksite State

CALIFORNIA

Worksite Postal Code

92121

Job Title

Staff Regulatory Affairs Specialist

Job Title Slug

staff-regulatory-affairs-specialist

Minimum Education

Bachelor's

Major Field of Study

See H.14

Required Training

N

Required Experience

Y

Required Experience Months

96

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

96

Accept Alternative Job Title

In the field of Medical Device Regulatory Affairs

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

H.4 and H.4B Bachelors degree or equivalent in Engineering Biomedical, Pharmaceutical, Electrical, Mechanical, or Chemical, Life Science Biology, Chemistry, Biochemistry, Microbiology, or Pharmacy or a related academic field.br br H.6 and H.10 Employer will accept pre or postbachelors degree experience.br br H.8C Employer will accept a Masters degree or equivalent in Engineering Biomedical, Pharmaceutical, Electrical, Mechanical, or Chemical, Life Science Biology, Chemistry, Biochemistry, Microbiology, or Pharmacy, or related academic field and 5 years of experience in the job offered or 5 years of experience in the field of Medical Device Regulatory Affairs in lieu of a Bachelors degree or equivalent and 8 years of experience.br br H.12 The requirements for the position are normal for the employer and within the industry. Employer marked not normal in H.12 due to ONET Job ZoneSVP analysis only.br br Work Experience to include 1 Experience with the U.S. and international regulatory requirements, including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality assurance, auditing principles, and adverse event reports. 2 Reading, analyzing, and interpreting business periodicals, professional journals, technical procedures, or governmental regulations that pertain to the medical device industry. 3 Writing project reports, business correspondence to Health Authorities or Industry organizations, and product procedure manuals. 4 Presenting regulatory information and responding to questions from groups of managers, clients, customers, regulatory authorities and the general public. 5 Arithmetic skills including averages, mean, standard deviation, variance, and percentages. 6 Creating and interpreting graphs and tables of clinical studies or regulatory submission statistics and data. 7 Interpreting and applying regulatory guidance to a new Company product or process. 8 Interpreting a variety of product or process instructions furnished in written, oral, diagram, or schedule form.br br Employer will accept any suitable combination of education, training, or experience.br br Employer requires background check.

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

2019-06-10

SWA Job Order End Date

2019-07-11

Sunday Edition Newspaper

Y

First Newspaper Name

The San Diego UnionTribune

First Advertisement Start Date

2019-06-16

Second Newspaper Ad Name

The San Diego UnionTribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-06-23

Employer Website From Date

2020-01-01 07:46:41

Employer Website To Date

2020-01-01 07:46:41

Professional Organization Ad From Date

2020-01-01 07:46:41

Professional Organization Advertisement To Date

2020-01-01 07:46:41

Job Search Website From Date

2019-06-16

Job Search Website To Date

2019-06-24

Employee Referral Program From Date

2020-01-01 07:46:41

Employee Referral Program To Date

2020-01-01 07:46:41

Local Ethnic Paper From Date

2019-06-21

Local Ethnic Paper To Date

2019-06-21

Radio/TV Ad From Date

2020-01-01 07:46:41

Radio/TV Ad To Date

2020-01-01 07:46:41

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

PHARMACEUTICAL SCIENCES

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

777785 W. 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

Amanda M Mullane

Preparer Title

Partner Attorney at Law

Preparer Email

[email protected]

Employer Information Declaration Name

Emi Benchuans

Employer Information Declaration Title

Sr. Manager, Employee Relations Compliance