Fiscal Year

2022

Case Number

A-21365-92458

Case Status

Certified

Received Date

2022-01-07

Decision Date

2022-08-31

Refile

N

Original File Date

2022-01-01 06:34:42

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

P10021197468189

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level III

PW Wage

88608.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-12-22

PW Expiration Date

2022-06-30

Wage Offer From

104000.00

Wage Offer To

0.00

Average Salary

104000.00

Wage Unit of Pay

Year

Worksite Address 1

15 Hampshire Street

Worksite Address 2

Worksite City

Mansfield

Worksite City Slug

mansfield

Worksite State

MASSACHUSETTS

Worksite Postal Code

2048

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 a closely related technical field

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

4

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

experience with Regulatory Affairs for Class II and Class III medical devices

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Requires a Masters degree in Regulatory Affairs or Biomedical Engineering, or a closely related technical field, and two 2 years of experience with Regulatory Affairs for Class II and Class III medical devices; OR alternatively, Bachelors degree in Regulatory Affairs or Biomedical Engineering, or a closely related technical field, and four 4 years of experience with Regulatory Affairs for Class II and Class III medical devices. Must possess a minimum of two 2 years of experience with each of the following 510k submissions; EU design dossiers, technical files, and change notifications; InSight and Agile systems; change assessment for device changes for regulatory implications; development and implementation of standard operating procedures for regulatory affairs activities; 21 CFR Parts 11, 50, 54, 56, 803, 806, 807, 812 and 814; and 21 CFR 820, ISO13485, and ISO14971. Position is open to telecommuting from anywhere in the U.S.

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

2021-09-27

SWA Job Order End Date

2021-10-28

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2021-10-03

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-10-10

Employer Website From Date

2021-09-27

Employer Website To Date

2021-11-28

Professional Organization Ad From Date

2022-01-01 06:34:42

Professional Organization Advertisement To Date

2022-01-01 06:34:42

Job Search Website From Date

2022-01-01 06:34:42

Job Search Website To Date

2022-01-01 06:34:42

Employee Referral Program From Date

2021-09-27

Employee Referral Program To Date

2021-10-12

Local Ethnic Paper From Date

2021-10-07

Local Ethnic Paper To Date

2021-10-07

Radio/TV Ad From Date

2022-01-01 06:34:42

Radio/TV Ad To Date

2022-01-01 06:34:42

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

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVE

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

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