Fiscal Year

2024

Case Number

A-22355-77426

Case Status

Certified

Received Date

2023-03-22

Decision Date

2024-04-05

Refile

N

Original File Date

2024-01-01 00:59:44

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

SMITH NEPHEW INC.

Employer Name Slug

smith-nephew-inc

Employer Address 1

1450 E BROOKS ROAD

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

7500

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 U Ramirez

Agent Attorney Firm Name

EY Law LLP

Agent Attorney Phone

4169324448

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 0B3

Agent Attorney Email

Emma.Ramirez@ca.ey.com

PW Track Number

P10022082003469

PW SOC Code

13-1041.07

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

103875.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-09-28

PW Expiration Date

2023-06-30

Wage Offer From

123600.00

Wage Offer To

0.00

Average Salary

123600.00

Wage Unit of Pay

Year

Worksite Address 1

150 Minuteman Rd

Worksite Address 2

Worksite City

Andover

Worksite City Slug

andover

Worksite State

MASSACHUSETTS

Worksite Postal Code

1810

Job Title

Sr. Regulatory Affairs Specialist

Job Title Slug

sr-regulatory-affairs-specialist

Minimum Education

Bachelor's

Major Field of Study

Biomedical Engineering

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biological Engineering or a closely 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

60

Accept Alternative Job Title

Related role in the Medical Device industry.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have a bachelors degree in Biomedical Engineering, Biological Engineering or a closely related field plus 5 years of postbaccalaureate experience in the job offered or related role in the medical device industry.br br Of the required experience, must have at least 5 years of experience in each of the followingbr br Regulatory Compliance, such as, but not limited to US FDA, EU MDD, EU MDR, or ISO 13485.br Product Development.br br Of the required experience, must have at least 2 years of experience in each of the followingbr br Change Control and evaluation of changes to quality management and design documentation, including evaluation of significant and nonsignificant changes.br Technical Documentation Creation and Maintenance under the European Medical Device Directive MDD and European Medical Device Regulation MDR.br International Registration Preparation and Submission.br Regulatory Process Management During Lifecycle of a Product.br Develop and Maintain Global Regulatory Strategies.

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

2022-10-19

SWA Job Order End Date

2022-11-23

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2022-10-23

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-10-30

Employer Website From Date

2022-10-18

Employer Website To Date

2022-12-23

Professional Organization Ad From Date

2024-01-01 00:59:44

Professional Organization Advertisement To Date

2024-01-01 00:59:44

Job Search Website From Date

2022-10-20

Job Search Website To Date

2022-11-02

Employee Referral Program From Date

2024-01-01 00:59:44

Employee Referral Program To Date

2024-01-01 00:59:44

Local Ethnic Paper From Date

2022-10-21

Local Ethnic Paper To Date

2022-10-21

Radio/TV Ad From Date

2024-01-01 00:59:44

Radio/TV Ad To Date

2024-01-01 00:59:44

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-4

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

BIOMEDICAL ENGINEERING

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

UNIVERSITY OF MUMBAI

Foreign Worker Education Institution Address 1

VIDYA NAGARI, KALINA, SANTACRUZ EAST,

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

MUMBAI

Foreign Worker Education Institution State/Province

MAHARASHTRA

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

400098

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 U Ramirez

Preparer Title

Attorney

Preparer Email

Emma.Ramirez@ca.ey.com

Employer Information Declaration Name

Carol Madison

Employer Information Declaration Title

Paralegal, Employment and Litigation