Fiscal Year

2024

Case Number

A-23031-95495

Case Status

Certified

Received Date

2023-03-08

Decision Date

2024-03-28

Refile

N

Original File Date

2024-01-01 01:03:40

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

34100

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

Zhu Cheng

Agent Attorney Firm Name

Fredrikson Byron, P.A.

Agent Attorney Phone

6124927399

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

55402

Agent Attorney Email

zcheng@fredlaw.com

PW Track Number

P10022054926220

PW SOC Code

13-1041.07

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

71926.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-09-26

PW Expiration Date

2023-06-30

Wage Offer From

86000.00

Wage Offer To

110000.00

Average Salary

98000.00

Wage Unit of Pay

Year

Worksite Address 1

710 Medtronic Parkway NE

Worksite Address 2

LC300

Worksite City

Minneapolis

Worksite City Slug

minneapolis

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

Regulatory Affairs

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biomedical Engineering or closely 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

Regulatory Affairs Specialist or related occupation in Regulatory Affairs

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Requires a Masters degree in Regulatory Affairs, Biomedical Engineering, or closely related field; and 2 years experience as a Regulatory Affairs Specialist or related occupation in Regulatory Affairs.br br Must possess at least 2 years experience with each of the followingbr br PreMarket Approval or 510k submissions for US Class III or Class II medical devicesbr MDD design dossiers, technical files and change notifications, or Design History Filesbr Total product lifecycle regulatory activities to include preclinical, clinical, approval, postapproval, and obsolescencebr 21 CFR Parts 11, 803, 806, 807, 814, 822, 830, and 860br QSR 21 CFR 820, EU MDD 9342EEC, CMDR, ISO 13485, and ISO 14971br br Multiple positions available.br This position is open to telecommuting from anywhere in the United States.

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

2022-10-17

SWA Job Order End Date

2022-11-18

Sunday Edition Newspaper

Y

First Newspaper Name

Star Tribune

First Advertisement Start Date

2022-10-23

Second Newspaper Ad Name

Star Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-10-30

Employer Website From Date

2022-10-17

Employer Website To Date

2022-12-17

Professional Organization Ad From Date

2024-01-01 01:03:40

Professional Organization Advertisement To Date

2024-01-01 01:03:40

Job Search Website From Date

2024-01-01 01:03:40

Job Search Website To Date

2024-01-01 01:03:40

Employee Referral Program From Date

2022-10-20

Employee Referral Program To Date

2022-11-03

Local Ethnic Paper From Date

2022-10-27

Local Ethnic Paper To Date

2022-11-02

Radio/TV Ad From Date

2024-01-01 01:03:40

Radio/TV Ad To Date

2024-01-01 01:03:40

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 AFFAIRS AND SERVICES

Foreign Worker Years of Education Completed

2019

Foreign Worker Institution of Education

ST. CLOUD STATE UNIVERSITY

Foreign Worker Education Institution Address 1

720 FOURTH AVENUE SOUTH

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

ST. CLOUD

Foreign Worker Education Institution State/Province

MN

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

56301

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Zhu Cheng

Preparer Title

Attorney

Preparer Email

zcheng@fredlaw.com

Employer Information Declaration Name

Lisa M Pedrys

Employer Information Declaration Title

Director, Medtronic Immigration Solutions Team