Fiscal Year

2021

Case Number

A-20318-20736

Case Status

Certified

Received Date

2020-11-20

Decision Date

2021-05-27

Refile

N

Original File Date

2021-01-01 09:29:40

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

46000

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

Constangy, Brooks, Smith Prophete, LLP

Agent Attorney Address 2

225 South 6th Street, Suite 1830

Agent Attorney City

Minneapolis

Agent Attorney State/Province

MINNESOTA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

554024504

Agent Attorney Email

psamaratunga@constangy.com

PW Track Number

P10020129554833

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

66019.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-08-25

PW Expiration Date

2021-06-30

Wage Offer From

92000.00

Wage Offer To

0.00

Average Salary

92000.00

Wage Unit of Pay

Year

Worksite Address 1

826 Coal Creek Circle

Worksite Address 2

Worksite City

Louisville

Worksite City Slug

louisville

Worksite State

COLORADO

Worksite Postal Code

80027

Job Title

Sr. Regulatory Affairs Specialist

Job Title Slug

sr-regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Regulatory Affairs, Biomedical Engineering or closely related field

Required Training

N

Required Experience

Y

Required Experience Months

12

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

12

Accept Alternative Job Title

Regulatory Affairs Specialist or Regulatory Affairs Associate

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

REQUIREMENTS Masters Degree in Regulatory Affairs, Biomedical Engineering or closely related field and one 1 year experience in Regulatory Affairs and one 1 year of postbachelors progressive experience in all of the following Regulatory submissions such as INDNDAANDA, 510k submissions and PMA PreMarket Approval applications, supplements and amendments; eCTD Modules, Design dossiers, technical files and change notifications for commercially released products; Presubmission meeting requests and interactions with regulatory agencies pertinent to submissions and deficiencies; Promotional material review for pharmaceuticalsdevices for compliance to national regulations; Pre and postmarket clinical documentation including clinical trial protocols, IB Investigators Brochure and Clinical Trial applications CTA to support regulatory submissions and regulatory meeting requests; Regulatory total product life cycle to include preclinical, clinical, approval, postapproval and obsolescence; Food Drug and Cosmetic Act and relevant PharmaceuticalMedical Device Regulations for preclinical and bench performance testing; Medical DevicePharmaceutical Quality Systems, GMPGLP and risk assessment tools to include 21 CFR 210 211, 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

2020-09-08

SWA Job Order End Date

2020-10-08

Sunday Edition Newspaper

Y

First Newspaper Name

Boulder Daily Camera

First Advertisement Start Date

2020-09-13

Second Newspaper Ad Name

Boulder Daily Camera

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-09-20

Employer Website From Date

2020-09-08

Employer Website To Date

2020-11-07

Professional Organization Ad From Date

2021-01-01 09:29:40

Professional Organization Advertisement To Date

2021-01-01 09:29:40

Job Search Website From Date

2021-01-01 09:29:40

Job Search Website To Date

2021-01-01 09:29:40

Employee Referral Program From Date

2020-09-08

Employee Referral Program To Date

2020-09-22

Local Ethnic Paper From Date

2020-09-17

Local Ethnic Paper To Date

2020-09-17

Radio/TV Ad From Date

2021-01-01 09:29:40

Radio/TV Ad To Date

2021-01-01 09:29:40

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

2017

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