Fiscal Year

2024

Case Number

A-22361-79570

Case Status

Certified-Expired

Received Date

2023-01-31

Decision Date

2024-03-22

Refile

N

Original File Date

2024-01-01 00:52:55

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Withings, Inc.

Employer Name Slug

withings-inc

Employer Address 1

225 Franklin St.

Employer Address 2

Suite 1250

Employer City

Boston

Employer City Slug

boston

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2110

Employer Phone

857-233-2681

Employer Number of Employees

260

Employer Year Commenced Business

2008

NAICS Code

334510

FW Ownership Interest

N

Employer Contact Name

Sara Douglas

Employer Contact Address 1

225 Franklin St.

Employer Contact Address 2

Suite 1250

Employer Contact City

Boston

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2110

Employer Contact Phone

857-233-2681

Employer Contact Email

sara.douglas@withings.com

Agent Attorney Name

Melina Villalobos

Agent Attorney Firm Name

Ogletree, Deakins, Nash, Smoak Stewart, P.C.

Agent Attorney Phone

9197603000

Agent Attorney Address 1

8529 Six Forms Rd

Agent Attorney Address 2

Forum IV, Suite 600

Agent Attorney City

Raleigh

Agent Attorney State/Province

NORTH CAROLINA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

27615

Agent Attorney Email

Melina.Villalobos@ogletree.com

PW Track Number

P10022024849449

PW SOC Code

11-9199.01

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level III

PW Wage

150176.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-08-09

PW Expiration Date

2023-06-30

Wage Offer From

150500.00

Wage Offer To

155500.00

Average Salary

153000.00

Wage Unit of Pay

Year

Worksite Address 1

225 Franklin St

Worksite Address 2

Suite 1250

Worksite City

Boston

Worksite City Slug

boston

Worksite State

MASSACHUSETTS

Worksite Postal Code

2110

Job Title

Regulatory Affairs Manager

Job Title Slug

regulatory-affairs-manager

Minimum Education

Master's

Major Field of Study

Regulatory Affairs

Required Training

N

Required Experience

Y

Required Experience Months

36

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Life Sciences or related 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

36

Accept Alternative Job Title

In the job offered or related occupation.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Applicants must have demonstrated experience withbr br US Class I, II or III medical devices;br US establishment and medical device registrations;br Different medical device types such as Electromechanical device with software and In vitro diagnostics devices;br Working directly with FDA, notified bodies or international health authorities;br Negotiating with regulatory authority personnel FDA and Notified Bodies in medical device and in vitro diagnostic areas;br International product registration;br US medical device regulations, 21 CFR 820 Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, and Good Laboratory Practice regulations;br Microsoft Word, Excel, Adobe and PowerPoint;br 510k submissions, Presubmissions, and Informational Meeting submission;br Working knowledge of 21 CFR 820 Quality System Regulation, ISO 13485, European medical device and in vitro device regulations and standards and FDA guidances;br Performing quality audits to comply with US regulations;br Reviewing labeling and marketing material to comply with US medical device labeling regulations and UDI requirements;br Monitoring regulatory changes and assessing their impact;br Training and promoting the quality and regulatory culture across the organization.

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

2022-10-17

SWA Job Order End Date

2022-11-19

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2022-10-09

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-10-16

Employer Website From Date

2024-01-01 00:52:55

Employer Website To Date

2024-01-01 00:52:55

Professional Organization Ad From Date

2024-01-01 00:52:55

Professional Organization Advertisement To Date

2024-01-01 00:52:55

Job Search Website From Date

2022-10-09

Job Search Website To Date

2022-10-23

Employee Referral Program From Date

2024-01-01 00:52:55

Employee Referral Program To Date

2024-01-01 00:52:55

Local Ethnic Paper From Date

2022-10-13

Local Ethnic Paper To Date

2022-10-13

Radio/TV Ad From Date

2022-10-13

Radio/TV Ad To Date

2022-10-13

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

Foreign Worker Years of Education Completed

2016

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

Melina Villalobos

Preparer Title

Attorney

Preparer Email

melina.villalobos@ogletreedeakins.com

Employer Information Declaration Name

Sara Douglas

Employer Information Declaration Title

US Director of HR