Fiscal Year

2020

Case Number

A-19317-82775

Case Status

Certified

Received Date

2019-12-02

Decision Date

2020-04-21

Refile

N

Original File Date

2020-01-01 08:17:14

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

COVIDIEN

Employer Name Slug

covidien

Employer Address 1

A MEDTRONIC COMPANY

Employer Address 2

710 MEDTRONIC PARKWAY LC300

Employer City

FRIDLEY

Employer City Slug

fridley

Employer State

MINNESOTA

Employer State Slug

minnesota

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

55432

Employer Phone

763-505-2710

Employer Number of Employees

14000

Employer Year Commenced Business

1960

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Lisa M Pedrys

Employer Contact Address 1

710 Medtronic Parkway NE, LC300

Employer Contact Address 2

Employer Contact City

Fridley

Employer Contact State/Province

MINNESOTA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

55432

Employer Contact Phone

763-505-2710

Employer Contact Email

Lisa.Marie.Pedrys@Medtronic.com

Agent Attorney Name

Loan T Huynh

Agent Attorney Firm Name

Fredrikson Byron, P.A.

Agent Attorney Phone

6124927165

Agent Attorney Address 1

200 South Sixth Street

Agent Attorney Address 2

Suite 4000

Agent Attorney City

Minneapolis

Agent Attorney State/Province

MINNESOTA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

550421425

Agent Attorney Email

lhuynh@fredlaw.com

PW Track Number

P10019176009759

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

68162.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-10-08

PW Expiration Date

2020-06-30

Wage Offer From

120000.00

Wage Offer To

0.00

Average Salary

120000.00

Wage Unit of Pay

Year

Worksite Address 1

5290 California Ave.

Worksite Address 2

Worksite City

Irvine

Worksite City Slug

irvine

Worksite State

CALIFORNIA

Worksite Postal Code

92617

Job Title

Sr. Regulatory Affairs Specialist

Job Title Slug

sr-regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Biomedical Engineering

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Regulatory Affairs

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

experience in regulatory affairs

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Requires a Masters degree in Regulatory Affairs or Biomedical Engineering and 2 years of experience in regulatory affairs; or Bachelors degree in Regulatory Affairs or Biomedical Engineering and 5 years of experience in regulatory affairs. Must possess a minimum of 2 years of experience with each of the following PMA PreMarket Approval or 510k submissions for US Class III and Class II medical devices; MDD Medical Device Directive design dossiers, technical files and change notifications; Pre and postmarket clinical investigations for Class III and Class II medical devices; total product lifecycle regulatory experience to include preclinical, clinical, approval, postapproval and obsolescence; Food Drug and Cosmetic Act and relevant Medical Device Regulations to include 21 CFR Parts 11,50,54,56,803,806,807,812,814; and Medical Device Quality Systems to include ISO13485 and ISO14971.

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

2019-06-18

SWA Job Order End Date

2019-07-19

Sunday Edition Newspaper

Y

First Newspaper Name

Los Angeles Times

First Advertisement Start Date

2019-06-23

Second Newspaper Ad Name

Los Angeles Times

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-06-30

Employer Website From Date

2019-06-12

Employer Website To Date

2019-08-20

Professional Organization Ad From Date

2020-01-01 08:17:14

Professional Organization Advertisement To Date

2020-01-01 08:17:14

Job Search Website From Date

2020-01-01 08:17:14

Job Search Website To Date

2020-01-01 08:17:14

Employee Referral Program From Date

2019-06-18

Employee Referral Program To Date

2019-07-02

Local Ethnic Paper From Date

2019-06-26

Local Ethnic Paper To Date

2019-06-26

Radio/TV Ad From Date

2020-01-01 08:17:14

Radio/TV Ad To Date

2020-01-01 08:17:14

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

BIOMEDICAL ENGINEERING

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

UNIVERSITY OF SOUTHERN CALIFORNIA

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

Loan T Huynh

Preparer Title

Attorney

Preparer Email

lhuynh@fredlaw.com

Employer Information Declaration Name

Lisa M Pedrys

Employer Information Declaration Title

Director, Medtronic Immigration Solutions Team