All Details of Green Card Application:
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Case Number: A-21242-37716
Fiscal year: 2022
Fiscal Year
2022
Case Number
A-21242-37716
Case Status
Certified
Received Date
2021-11-21
Decision Date
2022-05-12
Refile
N
Original File Date
2022-01-01 11:26:23
Previous SWA Case Number State
Schedule A Sheepherder
N
Employer Name
BOSTON SCIENTIFIC
Employer Name Slug
boston-scientific
Employer Address 1
300 BOSTON SCIENTIFIC WAY
Employer Address 2
Employer City
MARLBOROUGH
Employer City Slug
marlborough
Employer State
MASSACHUSETTS
Employer State Slug
massachusetts
Employer Country
UNITED STATES OF AMERICA
Employer Postal Code
1752
Employer Phone
508-650-8000
Employer Number of Employees
17000
Employer Year Commenced Business
1979
NAICS Code
339112
FW Ownership Interest
N
Employer Contact Name
Sarah Lopez
Employer Contact Address 1
300 Boston Scientific Way
Employer Contact Address 2
Employer Contact City
Marlborough
Employer Contact State/Province
MASSACHUSETTS
Employer Contact Country
UNITED STATES OF AMERICA
Employer Contact Postal Code
1752
Employer Contact Phone
508-683-4929
Employer Contact Email
Agent Attorney Name
Samantha D Wolfe
Agent Attorney Firm Name
Ogletree, Deakins, Nash, Smoak Stewart, P.C.
Agent Attorney Phone
(303) 764-6831
Agent Attorney Address 1
2000 South Colorado Blvd
Agent Attorney Address 2
Tower 3, Suite 900
Agent Attorney City
Denver
Agent Attorney State/Province
COLORADO
Agent Attorney Country
UNITED STATES OF AMERICA
Agent Attorney Postal Code
80222
Agent Attorney Email
PW Track Number
P10020227770095
PW SOC Code
11-9199
PW SOC Title
Regulatory Affairs Managers 119199.01
PW Skill Level
Level IV
PW Wage
164694.00
PW Unit of Pay
Year
PW Wage Source
OES
PW Determination Date
2021-01-21
PW Expiration Date
2021-06-30
Wage Offer From
164694.00
Wage Offer To
0.00
Average Salary
164694.00
Wage Unit of Pay
Year
Worksite Address 1
100 Boston Scientific Way
Worksite Address 2
Worksite City
Marlborough
Worksite City Slug
marlborough
Worksite State
MASSACHUSETTS
Worksite Postal Code
1752
Job Title
Principal Specialist, Regulatory Affairs
Job Title Slug
principal-specialist-regulatory-affairs
Minimum Education
Master's
Major Field of Study
Regulatory Affairs
Required Training
N
Required Experience
N
Required Experience Months
Accept Alternative Field of Study
Y
Accept Alternative Major Field of Study
Drug Regulatory Affairs, Biomechanical Engineering, or related field.
Accept Alternative Combination
Y
Accept Alternative Combination Education
Bachelor's
Accept Alternative Combination Education Years
5
Accept Foreign Education
Y
Accept Alternative Occupation
Y
Accept Alternative Occupation Months
36
Accept Alternative Job Title
Regulatory Affairs AssociateSpecialistConsultant, or related occupation.
Job Opportunity Requirements Normal
Y
Foreign Language Required
N
Specific Skills
Requires a Masters degree or Bachelors degree in Regulatory Affairs, Drug Regulatory Affairs, Biomechanical Engineering, or related field.br br Position requires progressive, postbachelors experience 3 years with Masters or 5 years with Bachelors which must include some experience in each of the following skills Training regulatory functional team members; Planning, coordinating, preparing FDA submissions 510Ks, PMAs, IDEs for new product approvalsclearances; Preparing and maintaining EU documentation including Technical Documentation in accordance with the Medical Device Directive MDD or Medical Device Regulation MDR; Experience supporting new product development projects and sustaining engineering projects for products registered in the US, EU and globally including Japan, China, and Canada; Experience conducting review of product and manufacturing changes for compliance with applicable regulations Change Control; Experience communicating with FDA, EU Competent Authorities, Notified Bodies, Health Canada, the Therapeutic Goods Administration, China FDA, and Japan PMDA to address global regulatory requirements for investigational and commercial distribution of products; and Experience with submissions and change control for medical electrical equipment capital devices, including IEC 60601 certifications.
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
2021-05-30
SWA Job Order End Date
2021-07-08
Sunday Edition Newspaper
Y
First Newspaper Name
The Boston Globe
First Advertisement Start Date
2021-06-13
Second Newspaper Ad Name
The Boston Globe
Second Advertisement Type
Newspaper
Second Ad Start Date
2021-06-20
Employer Website From Date
2022-01-01 11:26:23
Employer Website To Date
2022-01-01 11:26:23
Professional Organization Ad From Date
2022-01-01 11:26:23
Professional Organization Advertisement To Date
2022-01-01 11:26:23
Job Search Website From Date
2021-06-14
Job Search Website To Date
2021-06-29
Employee Referral Program From Date
2021-06-10
Employee Referral Program To Date
2021-06-29
Local Ethnic Paper From Date
2021-06-16
Local Ethnic Paper To Date
2021-06-16
Radio/TV Ad From Date
2022-01-01 11:26:23
Radio/TV Ad To Date
2022-01-01 11:26:23
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
DRUG REGULATORY AFFAIRS
Foreign Worker Years of Education Completed
2009
Foreign Worker Institution of Education
LONG ISLAND UNIVERSITY
Foreign Worker Education Institution Address 1
1 UNIVERSITY PLAZA
Foreign Worker Education Institution Address 2
Foreign Worker Education Institution City
BROOKLYN
Foreign Worker Education Institution State/Province
NY
Foreign Worker Education Institution Country
UNITED STATES OF AMERICA
Foreign Worker Education Institution Postal Code
11201
Foreign Worker Experience with Employer
N
Foreign Worker Employer Pays for Education
N
Foreign Worker Currently Employed
Y
Employer Completed Application
N
Preparer Name
Samantha D Wolfe
Preparer Title
Attorney
Preparer Email
Employer Information Declaration Name
Sarah Lopez
Employer Information Declaration Title
Sr. HR Operations Analyst