Fiscal Year

2022

Case Number

A-21148-93663

Case Status

Certified

Received Date

2021-07-09

Decision Date

2022-04-22

Refile

N

Original File Date

2022-01-01 11:18:37

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

9988

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

Loan T Huynh

Agent Attorney Firm Name

Fredrikson Byron, P.A.

Agent Attorney Phone

6124927165

Agent Attorney Address 1

200 South Sixth Street, Suite 4000

Agent Attorney Address 2

Agent Attorney City

Minneapolis

Agent Attorney State/Province

MINNESOTA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

55402

Agent Attorney Email

lhuynh@fredlaw.com

PW Track Number

P10020246802575

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

62400.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-02-09

PW Expiration Date

2021-06-30

Wage Offer From

85000.00

Wage Offer To

0.00

Average Salary

85000.00

Wage Unit of Pay

Year

Worksite Address 1

3880 Brickway Dr.

Worksite Address 2

Worksite City

Santa Rosa

Worksite City Slug

santa-rosa

Worksite State

CALIFORNIA

Worksite Postal Code

95403

Job Title

Regulatory Affairs Specialist

Job Title Slug

regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Regulatory Affairs/Science

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biomedical Engineering, Pharmacy or related medical clinical field

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

6

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 AffairsScience, Biomedical Engineering, Pharmacy or related medical clinical field and 6 months of experience in regulatory affairs. The position requires a minimum of 6 months of experience with each of the following preparing and reviewing pre and post market regulatory submissions for Class II and Class III medical devices in U.S. and EU; U.S. and EU Class II and Class III device regulations and reportability for product changes; medical device submissions and clearances including FDA medical device regulations and EU Medical Device Directive 200747EC; developing strategies for regulatory approval in U.S., EU, Japan, and Brazil; worldwide regulatory requirements 510k, IDE and PMA device product submissions; and 21 CFR 11, 800, 801, 803, 806, 807, 809, 820, ISO 13485 and ISO 14971.br br Experience maybe gained through internships, research, coursework andor work experience.

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

2021-03-03

SWA Job Order End Date

2021-04-02

Sunday Edition Newspaper

Y

First Newspaper Name

The Press Democrat

First Advertisement Start Date

2021-03-14

Second Newspaper Ad Name

The Press Democrat

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-03-21

Employer Website From Date

2021-03-01

Employer Website To Date

2021-05-03

Professional Organization Ad From Date

2022-01-01 11:18:37

Professional Organization Advertisement To Date

2022-01-01 11:18:37

Job Search Website From Date

2022-01-01 11:18:37

Job Search Website To Date

2022-01-01 11:18:37

Employee Referral Program From Date

2021-03-09

Employee Referral Program To Date

2021-03-23

Local Ethnic Paper From Date

2021-03-19

Local Ethnic Paper To Date

2021-03-25

Radio/TV Ad From Date

2022-01-01 11:18:37

Radio/TV Ad To Date

2022-01-01 11:18:37

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

REGULATORY SCIENCE

Foreign Worker Years of Education Completed

2016

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