Fiscal Year

2023

Case Number

A-22041-10212

Case Status

Certified

Received Date

2022-04-25

Decision Date

2022-12-21

Refile

N

Original File Date

2023-01-01 17:59:20

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

55402

Agent Attorney Email

lhuynh@fredlaw.com

PW Track Number

P10021099212316

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

72030.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-09-14

PW Expiration Date

2022-06-30

Wage Offer From

81000.00

Wage Offer To

0.00

Average Salary

81000.00

Wage Unit of Pay

Year

Worksite Address 1

6135 Gunbarrel Ave

Worksite Address 2

Worksite City

Boulder

Worksite City Slug

boulder

Worksite State

COLORADO

Worksite Postal Code

80301

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

Regulatory Science or related 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

12

Accept Alternative Job Title

experience in regulatory affairs

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Must possess a Masters degree in Regulatory Affairs, Regulatory Science or related field and one 1 year of experience in regulatory affairs.br br Must possess six 6 months of experience with each of the followingbr br Regulatory affairs for Class II or Class III medical devices;br United States medical device registration activities 510k and PMA support;br EU registration activities Technical Files;br Post market change assessments to include LetterToFile and Technical file updates;br Collection documents and review of Clinical Evaluation Reports for Class II medical devices;br Total product lifecycle regulatory activities to include preclinical, approval and postapproval; andbr Working in a Quality Management System environment 21 CFR 820, ISO13485 and ISO14971 and relevant Medical Device Regulations to include 21 CFR Parts 807 and 814.

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

2021-11-19

SWA Job Order End Date

2021-12-20

Sunday Edition Newspaper

Y

First Newspaper Name

Daily Camera

First Advertisement Start Date

2021-11-07

Second Newspaper Ad Name

Daily Camera

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-11-14

Employer Website From Date

2021-11-01

Employer Website To Date

2022-01-19

Professional Organization Ad From Date

2023-01-01 17:59:20

Professional Organization Advertisement To Date

2023-01-01 17:59:20

Job Search Website From Date

2023-01-01 17:59:20

Job Search Website To Date

2023-01-01 17:59:20

Employee Referral Program From Date

2021-11-01

Employee Referral Program To Date

2021-11-16

Local Ethnic Paper From Date

2021-11-11

Local Ethnic Paper To Date

2021-11-11

Radio/TV Ad From Date

2023-01-01 17:59:20

Radio/TV Ad To Date

2023-01-01 17:59:20

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

2018

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

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 Teams