Fiscal Year

2022

Case Number

A-21259-45849

Case Status

Certified

Received Date

2021-10-19

Decision Date

2022-04-19

Refile

N

Original File Date

2022-01-01 11:17:12

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

P10020345947584

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

N/A

PW Wage

120964.00

PW Unit of Pay

Year

PW Wage Source

Other

PW Determination Date

2021-06-08

PW Expiration Date

2021-09-06

Wage Offer From

125000.00

Wage Offer To

0.00

Average Salary

125000.00

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 Manager

Job Title Slug

regulatory-affairs-manager

Minimum Education

Master's

Major Field of Study

Medical Device and Diagnostic Engineering

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Regulatory Affairs or Biomedical Engineering

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

36

Accept Alternative Job Title

experience with regulatory affairs

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Requires a Masters degree in Regulatory Affairs, Biomedical Engineering or Medical Device and Diagnostic Engineering, and three 3 years experience with regulatory affairs. Must possess three 3 years of experience with each of the following EU Technical files and Design Dossiers; Premarket medical device submissions for US FDA and International submissions; communicate with regulatory agencies for presubmissions and submissions under review; review and approve advertising promotional material and product labelling for Class II and Class III medical devices; review change control documents and assess regulatory impact for external and internal documents for Class II and III medical devices; 21 CFR 11, 801, 803, 806, 807, 809, 820, ISO 13485, ISO 14971, EU Medical Device Directive EU MDD 9342EEC and Canadian Medical Device Regulation CMDR; and develop regulatory strategies for class II and class III medical devices. The following certification is required Regulatory Affairs Certification RAC.

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

2021-07-06

SWA Job Order End Date

2021-08-06

Sunday Edition Newspaper

Y

First Newspaper Name

Daily Camera Boulder

First Advertisement Start Date

2021-08-01

Second Newspaper Ad Name

Daily Camera Boulder

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-08

Employer Website From Date

2021-07-06

Employer Website To Date

2021-09-08

Professional Organization Ad From Date

2022-01-01 11:17:12

Professional Organization Advertisement To Date

2022-01-01 11:17:12

Job Search Website From Date

2022-01-01 11:17:12

Job Search Website To Date

2022-01-01 11:17:12

Employee Referral Program From Date

2021-07-06

Employee Referral Program To Date

2021-07-20

Local Ethnic Paper From Date

2021-07-15

Local Ethnic Paper To Date

2021-07-15

Radio/TV Ad From Date

2022-01-01 11:17:12

Radio/TV Ad To Date

2022-01-01 11:17:12

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CANADA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

MEDICAL DEVICE AND DIAGNOSTIC ENGINEERING

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LOS ANGELES

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

90007

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