Fiscal Year

2024

Case Number

A-23024-92234

Case Status

Certified

Received Date

2023-03-09

Decision Date

2024-03-29

Refile

N

Original File Date

2024-01-01 01:04:29

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

P10022062947889

PW SOC Code

11-9199.01

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

176696.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-09-04

PW Expiration Date

2023-06-30

Wage Offer From

176700.00

Wage Offer To

0.00

Average Salary

176700.00

Wage Unit of Pay

Year

Worksite Address 1

3880 Brickway Blvd

Worksite Address 2

Worksite City

Santa Rosa

Worksite City Slug

santa-rosa

Worksite State

CALIFORNIA

Worksite Postal Code

95403

Job Title

Regulatory Affairs Manager

Job Title Slug

regulatory-affairs-manager

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 related technical field

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

regulatory affairs specialist or related occupation in regulatory affairs in the medical device fld.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Requires a Masters degree in Regulatory Affairs, Biomedical Engineering, or related technical field and 3 years of experience as a regulatory affairs specialist or related occupation in regulatory affairs in the medical device field, or Bachelors degree in Regulatory Affairs, Biomedical Engineering, or related technical field and 5 years of experience as a regulatory affairs specialist or related occupation in regulatory affairs in the medical device field.br br Must possess 3 years of experience in each the followingbr br Developing regulatory strategies for approval in US, EU, Japan, Australia, China, and Canadabr Regulatory implications of post market manufacturing changesbr Preparing regulatory submissions for US Class III and Class II devices including IDE and IDE supplementsbr Preparing regulatory submissions EU Design Dossiers, Design Dossier Supplements and Technical Filesbr PreMarket Approval PMA applications, PMA Supplements, FDA presubmissions, Annual Reports, Post Approval study Reports, IDE Annual Progress Reports, 510ksbr Regulatory review of advertising and promotional materialsbr Global submissions including Japan Shonin, Health Canada new license or license amendment submissions, and China submissionsbr FDA Quality System Regulation QSR ISO 13485, ISO 14971, 21 CFR parts 807, 814, 820 and 821

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

The Press Democrat

First Advertisement Start Date

2022-10-23

Second Newspaper Ad Name

The Press Democrat

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 01:04:29

Professional Organization Advertisement To Date

2024-01-01 01:04:29

Job Search Website From Date

2024-01-01 01:04:29

Job Search Website To Date

2024-01-01 01:04:29

Employee Referral Program From Date

2022-10-18

Employee Referral Program To Date

2022-11-01

Local Ethnic Paper From Date

2022-10-28

Local Ethnic Paper To Date

2022-11-03

Radio/TV Ad From Date

2024-01-01 01:04:29

Radio/TV Ad To Date

2024-01-01 01:04:29

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

DRUG REGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

LONG ISLAND UNIVERSITY

Foreign Worker Education Institution Address 1

700 NORTHERN BOULEVARD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BROOKVILLE

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11548

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