DEXCOM, INC.

Manager, Regulatory Affairs

A-22252-19064 H-1B 2023 Certified

Salary

$176,550

Visa Type

H-1B

Job Title

Manager, Regulatory Affairs

Employee's Citizenship

INDIA

Graduate School

NORTHEASTERN UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22252-19064

Case Status Certified

Received Date 2022-10-10

Decision Date 2023-08-24

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 DEXCOM, INC.

Employer Address_Line 1 6340 SEQUENCE DRIVE

Employer Address_Line 2 -

Employer City SAN DIEGO

State -

Employer State/ Province CALIFORNIA

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 92121

Employer Phone No. (858) 875-9520

Employer Phone Extent No. -

Total Number of Employees 4500

Employer Year of Commenced 1999

NAICS Code 334510

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Melia Nicole Kunde

Employer Contact Address Line1 6310 Sequence Drive

Employer Contact Address Line2 -

Employer Contact City San Diego

Employer Contact State/ Provice CALIFORNIA

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 92121

Employer Contact Phone (858) 875-9761

Employer Contact Email nicole.kunde@dexcom.com

Attorney

11 fields

Agent/ Attorney Name Diana V Coker

Agent/ Attorney Firm Name Larrabee Albi Coker LLP

Agent/ Attorney Phone (858) 642-0420

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 Larrabee Albi Coker LLP

Agent/ Attorney Address Line 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 -

Agent/ Attorney Email diana@larrabee.com

Position Info

89 fields

Prevailing Wage Track Number P10021295663298

Prevailing Wage SOC Code 11-9199.01

Prevailing Wage SOC Title Regulatory Affairs Managers

Prevailing Wage Skill Level Level IV

Prevailing Wage 176550

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-04-26

Prevailing Wage Expiration Date 2022-07-25

Wage Offer From 176550

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 Remote employment, reporting to

Worksite Address Line 2 6340 Sequence Drive

Worksite City San Diego

Worksite State CALIFORNIA

Worksite Postal Code 92121

Job Title Manager, Regulatory Affairs

Minimum Education Bachelor's

Other Degree/ Diploma -

Major Field of Study See H.14

Required Training N

Required Training Month -

Required Field of Training -

Required Experience Y

Required Expreience Months 96

Accept Alternate Field of Study Y

Accept Alternate Major See H.4B

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 96

Accept Alternate Job Title Pharmaceutical Scientist or Pharmaceutical Engineer

Normal Requirements of Job Opportunity N

Required Foreign Language N

Specific Skills H.1 and H.2 This is a remote employment from anywhere in the United States reporting to Dexcom, Inc.s office at 6340 Sequence Drive, San Diego, CA 92121. Employee telecommutes and may report to the office once per quarter.br br H.4 and H.4B Bachelors degree or equivalent in Regulatory Science, Pharmaceutical Science, Chemistry, Chemical Engineering, Mechanical Engineering, Software Engineering, or a related academic field.br br H.6A 8 years of progressive experience in the job offered defined by employer as Regulatory Affairs. 8 years of experience must include 2 years of experience in a management or lead role.br br H.10A and H.10B 8 years of progressive experience in the occupation of Pharmaceutical Scientist or Pharmaceutical Engineer. 8 years of experience must include 2 years of experience in a management or lead role.br br H.12 Job requirements are normal for the employer due to the complexity of job duties associated with this position. Employer answered no to Question H.12 based on SVP analysis.br br Work experience to include 1 6 years of experience in the U.S. and Outside of U.S. premarket and postmarket medical device regulatory requirements. 2 6 years of experience with the medical device or pharmaceutical industry in the U.S., EMEA, or LATAM regions. 3 Managing crossfunctional projects. 4 Developing FDA and EU MDD Medical Device Directive or EU MDR Medical Device Regulation submissions for medical devices. 5 Providing regulatory strategy, regulatory guidance and change assessment for medical devices. 6 Preparing written reports and presentations on regulatory matters for management and customers, including medical professionals. 7 Making presentations to project management teams for regulatory plans and status updates. 8 Reviewing and signing medical product design and change documentation, test protocols and reports, product labeling, instructions for use, and manufacturing procedures documentation. 9 Participating in risk mitigation and control measure activities for medical devices. 10 Reviewing design change control documents, product recall documentation, field action documentation, validation reports, risk management reports, nonconforming material reports, corrective and preventive action plans and reports, and post market product surveillance reports. 11 Preparing domestic and international medical product submissions to regulatory agencies.br br Any and all experience may be gained concurrently.br br Position requires 10 domestic travel and 5 international travel; expenses paid by employer.br br Employer requires background checks.

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 2022-06-07

Job Oder End Date 2022-08-19

Sunday Edition Newspaper Y

First Newspaper Name The San Diego UnionTribune

First Advertisement Start Date 2022-06-12

Second Newspaper Name The San Diego UnionTribune

Second Advertisement Type Newspaper

Second Ad Start Date 2022-06-19

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 2022-06-12

Job Search Website to Date 2022-06-20

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date -

Employee Referral Program to Date -

Campus Placement from Date 2022-06-16

Campus Placement to Date 2022-06-23

Local Ethnic Newspaper from Date 2022-06-17

Local Ethnic Newspaper to Date 2022-06-17

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

Year of Compelted Education 2011

Foreign Worker Istitution of Eduation NORTHEASTERN UNIVERSITY

Foreign Worker Education Instution Address Line 1 360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City BOSTON

Foreign Worker Educatution Institution State MA

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 2115

Foreign Worker Training Completion N/A

Foreign Worker Required Experience Y

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience N

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name Diana V Coker

Preparer Title Partner Attorney at Law

Preparer Email diana@larrabee.com

Employer Information Declaration Name Melia Nicole Kunde

Employer Declaration Title Sr. Employee Relations Compliance Specialist