Fiscal Year

2022

Case Number

A-21227-31584

Case Status

Certified

Received Date

2021-09-07

Decision Date

2022-06-08

Refile

N

Original File Date

2022-01-01 11:36:22

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

P10020217750464

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

2021-01-12

PW Expiration Date

2021-06-30

Wage Offer From

102000.00

Wage Offer To

0.00

Average Salary

102000.00

Wage Unit of Pay

Year

Worksite Address 1

3540 Unocal Place

Worksite Address 2

Worksite City

Santa Rosa

Worksite City Slug

santa-rosa

Worksite State

CALIFORNIA

Worksite Postal Code

95403

Job Title

Sr. Regulatory Affairs Specialist

Job Title Slug

sr-regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Life Sciences

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Regulatory Science, Biomedical Engineering, or related medicalscientific 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 in regulatory affairs

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Requires a Masters degree in Regulatory Science, Biomedical Engineering, Life Sciences, or related medicalscientific field and two 2 years of experience in regulatory affairs. Must possess a minimum of two 2 years with each of the following; Regulatory affairs for Class III medical devices; Medical device submissions and clearances including FDA medical device regulations, Pharmaceuticals and Medical Devices Act and EU Medical Device Directive 200747EC; Developing strategies for regulatory approval in US, EU, Japan; Preparing global regulatory submissions PMAs, IDEs, EU Design Dossiers and Japan Shonins; 21 CFR 800, 801, 812, 814, 820; ISO 13485, ISO 5840 and ISO 14971; and Change management and documentation systems such as Regulatory Affairs Documentation RAD or Agile.

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

2021-04-26

SWA Job Order End Date

2021-05-27

Sunday Edition Newspaper

Y

First Newspaper Name

The Press Democrat

First Advertisement Start Date

2021-05-02

Second Newspaper Ad Name

The Press Democrat

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-05-09

Employer Website From Date

2021-04-26

Employer Website To Date

2021-06-29

Professional Organization Ad From Date

2022-01-01 11:36:22

Professional Organization Advertisement To Date

2022-01-01 11:36:22

Job Search Website From Date

2022-01-01 11:36:22

Job Search Website To Date

2022-01-01 11:36:22

Employee Referral Program From Date

2021-04-26

Employee Referral Program To Date

2021-05-10

Local Ethnic Paper From Date

2021-05-07

Local Ethnic Paper To Date

2021-05-13

Radio/TV Ad From Date

2022-01-01 11:36:22

Radio/TV Ad To Date

2022-01-01 11:36:22

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

AGRICULTURE AND LIFE SCIENCES

Foreign Worker Years of Education Completed

2012

Foreign Worker Institution of Education

CORNELL UNIVERSITY

Foreign Worker Education Institution Address 1

CORNELL UNIVERSITY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

ITHACA

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

14850

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