Fiscal Year

2022

Case Number

A-21274-52852

Case Status

Certified

Received Date

2021-10-26

Decision Date

2022-05-02

Refile

N

Original File Date

2022-01-01 11:22:36

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

COVIDIEN

Employer Name Slug

covidien

Employer Address 1

A MEDTRONIC COMPANY

Employer Address 2

710 MEDTRONIC PARKWAY LC300

Employer City

FRIDLEY

Employer City Slug

fridley

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

7647

Employer Year Commenced Business

1960

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Lisa M Pedrys

Employer Contact Address 1

710 Medtronic Parkway NE, LC300

Employer Contact Address 2

Employer Contact City

Fridley

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

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

550421425

Agent Attorney Email

lhuynh@fredlaw.com

PW Track Number

P10021032045027

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level III

PW Wage

79560.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-06-15

PW Expiration Date

2021-09-13

Wage Offer From

80000.00

Wage Offer To

0.00

Average Salary

80000.00

Wage Unit of Pay

Year

Worksite Address 1

2300 Berkshire Lane

Worksite Address 2

Suite 5

Worksite City

Plymouth

Worksite City Slug

plymouth

Worksite State

MINNESOTA

Worksite Postal Code

55441

Job Title

Regulatory Affairs Specialist

Job Title Slug

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 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

6

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 Affairs, Biomedical Engineering, or related medicalscientific field and six 6 months of experience in regulatory affairs. Must possess a minimum of six 6 months with each of the following Class II and Class III medical devices; medical device submissions and clearances including FDA medical device regulations and EU Medical Device Directive 200747EC; product changes, design changes, manufacturing changes, supplier changes, labeling changes, product registrations and audits; developing regulatory strategies, timelines, and deliverables for approval in U.S. and EU for medical devices or combination products; 510k, IDE and PMA device product submissions; ISO 13485 and ISO 14971; technical literature to include labeling, IFUs, manuals, patient guides, clinical literature and advertising promotion materials; and review, approval, and coordination of changes associated with product and process in electronic document control systems.

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

2021-07-19

SWA Job Order End Date

2021-08-19

Sunday Edition Newspaper

Y

First Newspaper Name

Star Tribune

First Advertisement Start Date

2021-07-25

Second Newspaper Ad Name

Star Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-01

Employer Website From Date

2021-07-19

Employer Website To Date

2021-09-20

Professional Organization Ad From Date

2022-01-01 11:22:36

Professional Organization Advertisement To Date

2022-01-01 11:22:36

Job Search Website From Date

2022-01-01 11:22:36

Job Search Website To Date

2022-01-01 11:22:36

Employee Referral Program From Date

2021-07-19

Employee Referral Program To Date

2021-08-02

Local Ethnic Paper From Date

2021-07-29

Local Ethnic Paper To Date

2021-08-04

Radio/TV Ad From Date

2022-01-01 11:22:36

Radio/TV Ad To Date

2022-01-01 11:22:36

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

2018

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