Fiscal Year

2021

Case Number

A-20286-09649

Case Status

Certified

Received Date

2020-10-22

Decision Date

2021-05-06

Refile

N

Original File Date

2021-01-01 09:20:50

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

MEDTRONIC, INC.

Employer Name Slug

medtronic-inc

Employer Address 1

710 MEDTRONIC PARKWAY

Employer Address 2

Employer City

MINNEAPOLIS

Employer City Slug

minneapolis

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

46000

Employer Year Commenced Business

1949

NAICS Code

334510

FW Ownership Interest

N

Employer Contact Name

Lisa M Pedrys

Employer Contact Address 1

710 Medtronic Parkway

Employer Contact Address 2

Employer Contact City

Minneapolis

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

Piyumi M Samaratunga

Agent Attorney Firm Name

Constangy, Brooks, Smith Prophete, LLP

Agent Attorney Phone

6123516804

Agent Attorney Address 1

Constangy, Brooks, Smith Prophete, LLP

Agent Attorney Address 2

225 South 6th Street, Suite 1830

Agent Attorney City

Minneapolis

Agent Attorney State/Province

MINNESOTA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

554024504

Agent Attorney Email

psamaratunga@constangy.com

PW Track Number

P10020099470171

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level III

PW Wage

82243.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-07-21

PW Expiration Date

2021-06-30

Wage Offer From

104000.00

Wage Offer To

0.00

Average Salary

104000.00

Wage Unit of Pay

Year

Worksite Address 1

18000 Devonshire Street

Worksite Address 2

Worksite City

Northridge

Worksite City Slug

northridge

Worksite State

CALIFORNIA

Worksite Postal Code

91325

Job Title

Sr. Regulatory Affairs Specialist

Job Title Slug

sr-regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Regulatory Affairs, Biomedical Engineering or Biotechnology

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

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

24

Accept Alternative Job Title

Jr. QualityRegulatory Associate, Regulatory Affairs Associate

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

REQUIREMENTS Masters degree in Regulatory Affairs, Biomedical Engineering or Biotechnology and two 2 years of experience in Regulatory Affairs and two 2 years of postbachelors progressive experience in all of the following US and EU submissions for Class III and Class II medical devices; Clinical investigation, clinical trial planning, clinical study designs, clinical protocol development, adverse event reporting for Class III and Class II medical devices; FDA requirements, guidance documents, Medical Device Directive, Food Drug and Cosmetic Act, ISO 14971 and ISO 13485; Establishment registration, Device listing and license renewal; US and international regulatory requirements including design control, manufacturing, marketing, labeling and promotion regulations; Coordinating manufacturing processes for regulatory strategy on existing product approval registration.

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

2020-08-10

SWA Job Order End Date

2020-09-09

Sunday Edition Newspaper

Y

First Newspaper Name

Los Angeles Times

First Advertisement Start Date

2020-08-16

Second Newspaper Ad Name

Los Angeles Times

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-08-23

Employer Website From Date

2020-08-10

Employer Website To Date

2020-10-09

Professional Organization Ad From Date

2021-01-01 09:20:50

Professional Organization Advertisement To Date

2021-01-01 09:20:50

Job Search Website From Date

2021-01-01 09:20:50

Job Search Website To Date

2021-01-01 09:20:50

Employee Referral Program From Date

2020-08-10

Employee Referral Program To Date

2020-08-24

Local Ethnic Paper From Date

2020-08-19

Local Ethnic Paper To Date

2020-08-19

Radio/TV Ad From Date

2021-01-01 09:20:50

Radio/TV Ad To Date

2021-01-01 09:20:50

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

BIOTECHNOLOGY

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

THE CALIFORNIA STATE UNIVERSITY

Foreign Worker Education Institution Address 1

333 S TWIN OAKS VALLEY RD.

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

SAN MARCOS

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

92096

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Piyumi M Samaratunga

Preparer Title

Attorney

Preparer Email

psamaratunga@constangy.com

Employer Information Declaration Name

Lisa M Pedrys

Employer Information Declaration Title

Director, Medtronic Immigration Solutions Team