Fiscal Year

2021

Case Number

A-20247-96007

Case Status

Certified

Received Date

2020-10-21

Decision Date

2021-05-10

Refile

N

Original File Date

2021-01-01 09:21:30

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

P10020056350959

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

65686.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-05-12

PW Expiration Date

2020-08-10

Wage Offer From

85000.00

Wage Offer To

0.00

Average Salary

85000.00

Wage Unit of Pay

Year

Worksite Address 1

7000 Central Ave. NE

Worksite Address 2

Worksite City

Fridley

Worksite City Slug

fridley

Worksite State

MINNESOTA

Worksite Postal Code

55432

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, Mechanical Engineering or related 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

24

Accept Alternative Job Title

experience with Class III medical device regulatory affairs

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Requires a Masters degree in Regulatory Affairs, Mechanical Engineering or Biomedical Engineering, or related field, and at minimum two 2 years experience with Class III medical device regulatory affairs. Must possess a minimum of two 2 years of experience with each of the following PMA PreMarket Approval for US Class III medical devices; Design dossiers, technical files and change notifications for AIMD and MDD medical devices; promotional material review for US Class III medical devices; writing and training for regulatory SOP Standard Operating Procedures; total product lifecycle regulatory activities to include preclinical, clinical, approval, postapproval and obsolescence; 21 CFR Parts 11, 50, 54, 56, 803, 806, 807, 812, and 814; and 21 CFR 820, ISO 13485, and ISO 14971.

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

2020-06-22

SWA Job Order End Date

2020-07-23

Sunday Edition Newspaper

Y

First Newspaper Name

Star Tribune

First Advertisement Start Date

2020-06-28

Second Newspaper Ad Name

Star Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-07-05

Employer Website From Date

2020-06-22

Employer Website To Date

2020-08-23

Professional Organization Ad From Date

2021-01-01 09:21:30

Professional Organization Advertisement To Date

2021-01-01 09:21:30

Job Search Website From Date

2021-01-01 09:21:30

Job Search Website To Date

2021-01-01 09:21:30

Employee Referral Program From Date

2020-06-22

Employee Referral Program To Date

2020-07-07

Local Ethnic Paper From Date

2020-07-02

Local Ethnic Paper To Date

2020-07-08

Radio/TV Ad From Date

2021-01-01 09:21:30

Radio/TV Ad To Date

2021-01-01 09:21:30

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

2015

Foreign Worker Institution of Education

THE UNIVERSITY OF TEXAS AT ARLINGTON

Foreign Worker Education Institution Address 1

701 S NEDDERMAN DR.

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

ARLINGTON

Foreign Worker Education Institution State/Province

TX

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

76019

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