Fiscal Year

2022

Case Number

A-21258-44435

Case Status

Certified

Received Date

2021-10-08

Decision Date

2022-04-13

Refile

N

Original File Date

2022-01-01 11:14:56

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

16000

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

Emmalyn Ramirez

Agent Attorney Firm Name

EY Law LLP

Agent Attorney Phone

416 943 3557

Agent Attorney Address 1

100 Adelaide Street West

Agent Attorney Address 2

Floor 31

Agent Attorney City

Toronto

Agent Attorney State/Province

Ontario

Agent Attorney Country

CANADA

Agent Attorney Postal Code

M5H OB3

Agent Attorney Email

Emma.Ramirez@ca.ey.com

PW Track Number

P10020346953369

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

53997.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-04-23

PW Expiration Date

2021-07-22

Wage Offer From

94484.00

Wage Offer To

0.00

Average Salary

94484.00

Wage Unit of Pay

Year

Worksite Address 1

7000 W. William Cannon Dr. Bldg One

Worksite Address 2

Worksite City

Austin

Worksite City Slug

austin

Worksite State

TEXAS

Worksite Postal Code

78735

Job Title

Senior Regulatory Affairs Specialist

Job Title Slug

senior-regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Bioengineering

Required Training

N

Required Experience

Y

Required Experience Months

12

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biomedical Engineering, or a related scientific field

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

3

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

12

Accept Alternative Job Title

Regulatory Experience in the Medical Device Industry

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Must have a masters degree in Bioengineering, Biomedical Engineering, or a related scientific field plus 1 year of regulatory experience in the medical device industry, OR a bachelors degree in Bioengineering, Biomedical Engineering, or a related scientific field plus 3 years of regulatory experience in the medical device industry.br br Of the required experience, must have 1 year of experience in each of the followingbr Providing Regulatory Strategy Advice to cross functional business teams.br Preparing and reviewing technical file including labelling and instructions for use and works with relevant crossfunctional teams to resolve issues.br Communicating changes to global markets and providing submission deliverables to International regions.br Assisting with Notified Body technical audits, responding to any deficiencies.br Developing and maintaining procedures and systems to ensure that the process addresses all regulatory requirements and business objectives.br US FDA, EU Medical Device Regulations, CE mark process, and industry standards.

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

2021-07-28

SWA Job Order End Date

2021-09-02

Sunday Edition Newspaper

Y

First Newspaper Name

Austin AmericanStatesman

First Advertisement Start Date

2021-06-20

Second Newspaper Ad Name

Austin AmericanStatesman

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-06-27

Employer Website From Date

2021-06-17

Employer Website To Date

2021-07-22

Professional Organization Ad From Date

2022-01-01 11:14:56

Professional Organization Advertisement To Date

2022-01-01 11:14:56

Job Search Website From Date

2021-06-14

Job Search Website To Date

2021-06-28

Employee Referral Program From Date

2022-01-01 11:14:56

Employee Referral Program To Date

2022-01-01 11:14:56

Local Ethnic Paper From Date

2021-06-18

Local Ethnic Paper To Date

2021-06-18

Radio/TV Ad From Date

2022-01-01 11:14:56

Radio/TV Ad To Date

2022-01-01 11:14:56

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

BIOENGINEERING

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

UNIVERSITY OF ILLINOIS CHICAGO

Foreign Worker Education Institution Address 1

1200 W HARRISON ST.

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CHICAGO

Foreign Worker Education Institution State/Province

IL

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

60607

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Emmalyn Ramirez

Preparer Title

Attorney

Preparer Email

Emma.Ramirez@ca.ey.com

Employer Information Declaration Name

Carol Madison

Employer Information Declaration Title

Legal Assistant Legal Records Assistant II