Fiscal Year

2020

Case Number

A-20016-07515

Case Status

Certified

Received Date

2020-03-30

Decision Date

2020-08-07

Refile

N

Original File Date

2020-01-01 08:31:36

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

PHILIPS MEDICAL SYSTEMS CLEVELAND, INC.

Employer Name Slug

philips-medical-systems-cleveland-inc

Employer Address 1

595 MINER ROAD

Employer Address 2

Employer City

HIGHLAND HEIGHTS

Employer City Slug

highland-heights

Employer State

OHIO

Employer State Slug

ohio

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

44143

Employer Phone

978-659-3075

Employer Number of Employees

22000

Employer Year Commenced Business

1921

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Barbara Bickford

Employer Contact Address 1

3000 Minuteman Road, Building 1, MS 1203

Employer Contact Address 2

Employer Contact City

Andover

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

1810

Employer Contact Phone

978-659-4844

Employer Contact Email

Barbara.Bickford@philips.com

Agent Attorney Name

Kristi Nevarez

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

408-919-0600

Agent Attorney Address 1

2121 Tasman Drive

Agent Attorney Address 2

Agent Attorney City

Santa Clara

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

95054

Agent Attorney Email

philips@fragomen.com

PW Track Number

P10019095428978

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

53976.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-07-22

PW Expiration Date

2020-06-30

Wage Offer From

95000.00

Wage Offer To

0.00

Average Salary

95000.00

Wage Unit of Pay

Year

Worksite Address 1

100 Park Avenue

Worksite Address 2

Suite 300

Worksite City

Orange Village

Worksite City Slug

orange-village

Worksite State

OHIO

Worksite Postal Code

44122

Job Title

Regulatory Affairs Specialist

Job Title Slug

regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

Technical

Required Training

N

Required Experience

Y

Required Experience Months

12

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Healthcare or Business 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

12

Accept Alternative Job Title

In job offered, or as Regulatory Specialist, or related occupation

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Experience with each of the following experience may be gained concurrently Interpretation of US, Europe, Canada, China, Russia, Korea, Japan and ten other countries medical device registration and marketing authorization regulations; Working with crossfunctional teams to convey regulatory requirements to be implemented in medical device including new product development, design planning, and manufacturing; Regulatory Technical Writing 510k, Technical Files, Design Dossiers Global Countries submission; Regulatory Technical Presentation and negotiation with Regulatory Bodies Reviewer and Auditors; Medical device regulations 21CFR and FDA law, and EU MDD; Global Regulatory Standards, Quality Management Systems, Design Controls regulations.

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

2020-01-15

SWA Job Order End Date

2020-02-18

Sunday Edition Newspaper

Y

First Newspaper Name

The Plain Dealer

First Advertisement Start Date

2019-10-06

Second Newspaper Ad Name

The Plain Dealer

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-10-13

Employer Website From Date

2020-01-01 08:31:36

Employer Website To Date

2020-01-01 08:31:36

Professional Organization Ad From Date

2019-10-07

Professional Organization Advertisement To Date

2019-10-21

Job Search Website From Date

2019-10-08

Job Search Website To Date

2019-10-22

Employee Referral Program From Date

2020-01-01 08:31:36

Employee Referral Program To Date

2020-01-01 08:31:36

Local Ethnic Paper From Date

2019-10-10

Local Ethnic Paper To Date

2019-10-10

Radio/TV Ad From Date

2020-01-01 08:31:36

Radio/TV Ad To Date

2020-01-01 08:31:36

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, BIOLOGIES AND MEDICAL SCIENCES

Foreign Worker Years of Education Completed

2014

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

02115-5000

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Kristi Nevarez

Preparer Title

Partner

Preparer Email

philips@fragomen.com

Employer Information Declaration Name

Barbara Bickford

Employer Information Declaration Title

Senior Paralegal