Fiscal Year

2022

Case Number

A-21208-23273

Case Status

Certified-Expired

Received Date

2021-09-03

Decision Date

2022-02-28

Refile

N

Original File Date

2022-01-01 10:59:54

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

SMITH NEPHEW INC.

Employer Name Slug

smith-nephew-inc

Employer Address 1

1450 BROOKS RD

Employer Address 2

Employer City

MEMPHIS

Employer City Slug

memphis

Employer State

TENNESSEE

Employer State Slug

tennessee

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

38116

Employer Phone

901-399-5687

Employer Number of Employees

6110

Employer Year Commenced Business

1975

NAICS Code

33911

FW Ownership Interest

N

Employer Contact Name

Carol Madison

Employer Contact Address 1

1450 Brooks RD

Employer Contact Address 2

Employer Contact City

Memphis

Employer Contact State/Province

TENNESSEE

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

38116

Employer Contact Phone

901-399-6044

Employer Contact Email

carol.madison@smith-nephew.com

Agent Attorney Name

Timothy G Payne

Agent Attorney Firm Name

Sidley Austin LLP

Agent Attorney Phone

(312) 853-7000

Agent Attorney Address 1

1 South Dearborn Street

Agent Attorney Address 2

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60603

Agent Attorney Email

tpayne@sidley.com

PW Track Number

P10020147601893

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

71032.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-09-15

PW Expiration Date

2021-06-30

Wage Offer From

105000.00

Wage Offer To

0.00

Average Salary

105000.00

Wage Unit of Pay

Year

Worksite Address 1

150 Minuteman Road

Worksite Address 2

Worksite City

Andover

Worksite City Slug

andover

Worksite State

MASSACHUSETTS

Worksite Postal Code

1810

Job Title

Senior Regulatory Affairs Specialist

Job Title Slug

senior-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

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

12

Accept Alternative Job Title

regulation of medical devices

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have work experience in each of the following knowledge of federal and international regulatory standards including USFDA 21 CFR 820, 800861 510K, PMA, EU MDR MDD 9342 EEC, CMDR SOR98282, ARGMD, NMPA, ANVISA, PMDA, and MFDS; knowledge of IEC 606011, IEC 606012, IEC 62304, ISO 10993, ISO 14971, ISO 13485, ISO 17665, MEDDEV 2.7.1, MEDEV 2.121, and ISO 62366; and experience responding to FDA, MDSAP and other regulatory and notified body audits.

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

2021-03-11

SWA Job Order End Date

2021-04-12

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-03-14

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-03-21

Employer Website From Date

2021-03-08

Employer Website To Date

2021-04-26

Professional Organization Ad From Date

2022-01-01 10:59:54

Professional Organization Advertisement To Date

2022-01-01 10:59:54

Job Search Website From Date

2021-03-15

Job Search Website To Date

2021-03-22

Employee Referral Program From Date

2022-01-01 10:59:54

Employee Referral Program To Date

2022-01-01 10:59:54

Local Ethnic Paper From Date

2021-03-19

Local Ethnic Paper To Date

2021-03-19

Radio/TV Ad From Date

2022-01-01 10:59:54

Radio/TV Ad To Date

2022-01-01 10:59:54

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

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

Timothy G Payne

Preparer Title

Partner

Preparer Email

tpayne@sidley.com

Employer Information Declaration Name

Carol Madison

Employer Information Declaration Title

Legal Assistant