Fiscal Year

2024

Case Number

A-23026-93385

Case Status

Certified-Expired

Received Date

2023-02-13

Decision Date

2024-03-12

Refile

N

Original File Date

2024-01-01 00:54:51

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

34000

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

Piyumi M Samaratunga

Agent Attorney Firm Name

Constangy, Brooks, Smith Prophete LLP

Agent Attorney Phone

6123516804

Agent Attorney Address 1

225 South 6th Street

Agent Attorney Address 2

Suite 1830

Agent Attorney City

Minneapolis

Agent Attorney State/Province

MINNESOTA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

55402

Agent Attorney Email

psamaratunga@constangy.com

PW Track Number

P10022089021826

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

69285.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-10-06

PW Expiration Date

2023-06-30

Wage Offer From

128000.00

Wage Offer To

0.00

Average Salary

128000.00

Wage Unit of Pay

Year

Worksite Address 1

18000 Devonshire Street

Worksite Address 2

Worksite City

Northridge

Worksite City Slug

northridge

Worksite State

CALIFORNIA

Worksite Postal Code

91325

Job Title

Sr. Regulatory Affairs Specialist- Pre-Market Approval

Job Title Slug

sr-regulatory-affairs-specialist-pre-market-approval

Minimum Education

Master's

Major Field of Study

Regulatory Affairs or Biomedical Engineering

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

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

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Experience must include two 2 years of postbachelors progressive experience in all of the following Strategy development for US Class III Medical Device PMA PreMarket Approval; MDD Medical Device Directive design dossiers, technical files and change notifications; Premarket clinical investigations for Class III and Class II medical devices; Total product lifecycle regulatory experience to include preclinical, clinical, approval, postapproval and obsolescence; Food Drug and Cosmetic Act and relevant Medical Device Regulations to include 21 CFR Parts 11, 807,812,814, 820; Medical Device Quality Systems to include ISO13485 and ISO14971.

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

2022-10-03

SWA Job Order End Date

2022-11-02

Sunday Edition Newspaper

Y

First Newspaper Name

Los Angeles Times

First Advertisement Start Date

2022-10-09

Second Newspaper Ad Name

Los Angeles Times

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-10-16

Employer Website From Date

2022-10-03

Employer Website To Date

2022-12-03

Professional Organization Ad From Date

2024-01-01 00:54:51

Professional Organization Advertisement To Date

2024-01-01 00:54:51

Job Search Website From Date

2024-01-01 00:54:51

Job Search Website To Date

2024-01-01 00:54:51

Employee Referral Program From Date

2022-10-03

Employee Referral Program To Date

2022-10-18

Local Ethnic Paper From Date

2022-10-12

Local Ethnic Paper To Date

2022-10-14

Radio/TV Ad From Date

2024-01-01 00:54:51

Radio/TV Ad To Date

2024-01-01 00:54:51

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 FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Piyumi M Samaratunga

Preparer Title

Attorney

Preparer Email

psamaratunga@constangy.com

Employer Information Declaration Name

Lisa M Pedrys

Employer Information Declaration Title

Director, Medtronic Immigration Solutions Team