Fiscal Year

2022

Case Number

A-21148-93338

Case Status

Certified-Expired

Received Date

2021-05-28

Decision Date

2021-12-10

Refile

N

Original File Date

2022-01-01 10:34:29

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Sanvita Medical Corporation

Employer Name Slug

sanvita-medical-corporation

Employer Address 1

165 Lexington Road

Employer Address 2

Employer City

Billerica

Employer City Slug

billerica

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

1821

Employer Phone

781-647-3700

Employer Number of Employees

31

Employer Year Commenced Business

2016

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

2454

Employer Contact Phone

781-647-3700

Employer Contact Email

mgatti@novabio.com

Agent Attorney Name

Sara M Fleming

Agent Attorney Firm Name

FordMurray

Agent Attorney Phone

207-613-7331

Agent Attorney Address 1

66 Pearl Street

Agent Attorney Address 2

Ste 311

Agent Attorney City

Portland

Agent Attorney State/Province

MAINE

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

4101

Agent Attorney Email

sfleming@fordmurraylaw.com

PW Track Number

P10020237784688

PW SOC Code

13-1041

PW SOC Title

Senior Regulatory Affairs Specialist

PW Skill Level

Level III

PW Wage

85966.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-01-29

PW Expiration Date

2021-06-30

Wage Offer From

85966.00

Wage Offer To

0.00

Average Salary

85966.00

Wage Unit of Pay

Year

Worksite Address 1

165 Lexington Road

Worksite Address 2

Worksite City

Billerica

Worksite City Slug

billerica

Worksite State

MASSACHUSETTS

Worksite Postal Code

1821

Job Title

Senior Regulatory Affairs Specialist

Job Title Slug

senior-regulatory-affairs-specialist

Minimum Education

Master's

Major Field of Study

MSc in Regulatory Affairs or related

Required Training

N

Required Experience

Y

Required Experience Months

36

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

36

Accept Alternative Job Title

Regulatory affairs or related

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

EXPERIENCE MUST INCLUDE AT LEAST 3 YEARS WORKING ON CGM PRODUCT LINES WITH AT LEAST 3 YEARS OF EXPERIENCE WORKING WITH THREE OF THE FOLLOWING CREATING 510K AND TECHNICAL FILES FOR CGM DEVICE; HEALTH CANADA APPLICATIONS; EUINTERNATIONAL MEDICAL DEVICE SUBMISSIONS;LICENSING AND REGISTRATION EXPERIENCE FOR CGM PRODUCTS; REGULATORY LABELING REVIEW EXPERIENCE; KNOWLEDGE OF ISO 13485, FDA QSR, MDDMDR,AND MDSAP.

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

2021-02-18

SWA Job Order End Date

2021-03-22

Sunday Edition Newspaper

Y

First Newspaper Name

Lowell Sun

First Advertisement Start Date

2021-03-14

Second Newspaper Ad Name

Lowell Sun

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-03-21

Employer Website From Date

2022-01-01 10:34:29

Employer Website To Date

2022-01-01 10:34:29

Professional Organization Ad From Date

2022-01-01 10:34:29

Professional Organization Advertisement To Date

2022-01-01 10:34:29

Job Search Website From Date

2021-03-15

Job Search Website To Date

2021-03-29

Employee Referral Program From Date

2022-01-01 10:34:29

Employee Referral Program To Date

2022-01-01 10:34:29

Local Ethnic Paper From Date

2021-03-18

Local Ethnic Paper To Date

2021-03-18

Radio/TV Ad From Date

2021-03-17

Radio/TV Ad To Date

2021-03-17

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

N

Employer Completed Application

N

Preparer Name

Sara M Fleming

Preparer Title

Attorney

Preparer Email

sfleming@fordmurraylaw.com

Employer Information Declaration Name

Mike Gatti

Employer Information Declaration Title

Manager, Benefits Compensation