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Case Number: A-21238-36427

Fiscal year: 2022

Fiscal Year

2022

Case Number

A-21238-36427

Case Status

Certified

Received Date

2021-10-26

Decision Date

2022-04-28

Refile

N

Original File Date

2022-01-01 11:21:20

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Nova Biomedical

Employer Name Slug

nova-biomedical

Employer Address 1

200 Prospect Street

Employer Address 2

Employer City

Waltham

Employer City Slug

waltham

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2454

Employer Phone

781-647-3700

Employer Number of Employees

1100

Employer Year Commenced Business

1976

NAICS Code

334516

FW Ownership Interest

N

Employer Contact Name

Michael Gatti

Employer Contact Address 1

200 Prospect Street

Employer Contact Address 2

Employer Contact City

Waltham

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2453

Employer Contact Phone

781-647-3700 214

Employer Contact Email

mgatti@novabio.com

Agent Attorney Name

Russell C Ford

Agent Attorney Firm Name

FordMurray

Agent Attorney Phone

207-613-7331

Agent Attorney Address 1

48 Free Street

Agent Attorney Address 2

Ste 300

Agent Attorney City

Portland

Agent Attorney State/Province

MAINE

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

4101

Agent Attorney Email

russell@fordmurraylaw.com

PW Track Number

P10020364982817

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level III

PW Wage

85966.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-05-11

PW Expiration Date

2021-08-09

Wage Offer From

85966.00

Wage Offer To

0.00

Average Salary

85966.00

Wage Unit of Pay

Year

Worksite Address 1

200 Prospect Street

Worksite Address 2

Worksite City

Waltham

Worksite City Slug

waltham

Worksite State

MASSACHUSETTS

Worksite Postal Code

2454

Job Title

Regulatory Affairs Specialist 1

Job Title Slug

regulatory-affairs-specialist-1

Minimum Education

Master's

Major Field of Study

Regulatory Affairs

Required Training

N

Required Experience

Y

Required Experience Months

6

Accept Alternative Field of Study

N

Accept Alternative Major 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

6

Accept Alternative Job Title

Regulatory Affairs Specialist or Related

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

KNOWLEDGE OF ISO 13485, FDA QSR, AND IVDDIVDR. 6 MONTHS OF EXPERIENCE WITH IVD OR MEDICAL DEVICES MUST INCLUDE WORK WITH 510K, HEALTH CANADA, AND INTERNATIONAL DEVICE SUBMISSIONS; LICENSING AND REGISTRATION; AND REGULATORY LABELING REVIEW.

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

2021-05-12

SWA Job Order End Date

2021-06-12

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-06-06

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-06-13

Employer Website From Date

2021-06-09

Employer Website To Date

2021-06-24

Professional Organization Ad From Date

2022-01-01 11:21:20

Professional Organization Advertisement To Date

2022-01-01 11:21:20

Job Search Website From Date

2021-06-08

Job Search Website To Date

2021-06-22

Employee Referral Program From Date

2022-01-01 11:21:20

Employee Referral Program To Date

2022-01-01 11:21:20

Local Ethnic Paper From Date

2021-06-10

Local Ethnic Paper To Date

2021-06-10

Radio/TV Ad From Date

2022-01-01 11:21:20

Radio/TV Ad To Date

2022-01-01 11:21:20

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

2018

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

Russell C Ford

Preparer Title

Attorney

Preparer Email

russell@fordmurraylaw.com

Employer Information Declaration Name

Michael Gatti

Employer Information Declaration Title

Manager, Benefits Compensation