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ABBOTT CARDIOVASCULAR SYSTEMS INC (Santa Clara, CALIFORNIA)
Job Title: Regulatory Affairs Specialist
Wage Rate: $95,000.00
Employer Business Identification
Employer Name
ABBOTT CARDIOVASCULAR SYSTEMS INC
Fiscar Year
2023
Case Status
Withdrawn
Case Number
A-23004-82133
Received Date
2/2/23
2007 NAICS US Code
32541
Job Title
Regulatory Affairs Specialist
Country of Citizenship
TAIWAN
Prevailing Wage Information
SOC Code
13-1041.07
Level
Level II
Wage Rate
82534.0
SOC Title
Regulatory Affairs Specialists
Source
OES
Wage Rate & Work Location
Wage Rate
$95,000.00 to 105,000.00 per year
City
Santa Clara
State
CALIFORNIA
Contact & Attorney Information
Attorney Firm Name
Hussain, Bendersky, and Liston LLC
Attorney Name
Keith P Liston
Attorney Location
Chicago, ILLINOIS
Others
Decision Date
6/23/23
Refile
N
Scheduled A Sheepherder
N
Employer Phone
(224) 667-8130
Employer Number of Employees
113000
Employer Year of Commenced Business
1888
FW Ownership Interest
N
Employer Contact Name
Kathleen Ellwanger
Employer Contact Address 1
100 Abbott Park Road
Employer Contact City
Abbott Park
Employer Contact State/Province
ILLINOIS
Employer Contact Postal Code
60064
Employer Contact Phone
(224) 667-8130
Employer Contact Email
[email protected]
Agent Attorney Phone
(312) 464-9330
Agent Attorney Email
[email protected]
Prevailing Wage Tracking Number
P10022109084224
Prevailing Wage Determination Date
11/1/22
Prevailing Wage Expiration Date
6/30/23
Minimum Education
Bachelor's
Major Field Of Study
Biomedical Engineering
Required Training
N
Required Expirence
N
Acceptable Alternate Field Of Study
Y
Acceptable Alternate Major Field Of Study
See H.14.
Acceptable Alternate Combination
N
Foreign Education Acceptable
Y
Alternate Occupation Experience Acceptable
Y
Alternate Occupation Experience Months
36
Alternate Occupation Job Title
Medical Product Manager, Regulatory Affairs Associate, or related
Job Opportunity Requirements Normal
Y
Foreign Language Required
N
Specific Skills
Bachelors or foreign equivalent degree in Biomedical Engineering, PharmacyPharmacology, BiochemistryImmunobiology, Regulatory AffairsScience or in a closely related regulatory affairs, quality, or biological science field with at least 3 years of experience in i ensuring and coordinating compliance with quality management system regulatory requirements for medical devices throughout product lifecycle, including ISO 13485, FDA 21 CFR 820, EU MDD, and equivalent local regulations for medical devices; ii providing regulatory representation and support for quality management system and product lifecycle change management; iii preparing, submitting, and maintaining domestic and international technical files, product registrations and licensing applications for Class II or higher medical devices; and iv understanding, investigating, and evaluating regulatory historybackground of class, disease therapeuticdiagnostic context to assess regulatory implications for approval, and determining trade issues to anticipate regulatory obstacles.
Combination of Occupations
N
Offered To Foreign Worker
Y
Foreign Worker live in Employer Premises
N
Live-in Domestic Service Worker
N
Professional Occupation
Y
College or University Teacher
N
SWA Job Order Start Date
11/1/22
SWA Job Order End Date
12/1/22
Sunday Edition News Paper
Y
First News Paper Name
San Francisco Chronicle
First Advertisement Start Date
11/6/22
Second News Paper Ad Name
San Francisco Chronicle
Second Advertisement Type
Newspaper
Second Ad Start Date
11/20/22
Job Search Website From Date
11/3/22
Job Search Webiste To Date
11/18/22
Employee Referral Program From Date
11/28/22
Employee Referral Program To Date
12/12/22
Local Ethnic Paper From Date
11/9/22
Local Ethnic Paper To Date
11/15/22
Employer Received Payment
N
Bargaining Representative Notified
N/A
Posted Notice At Worksite
Y
Layoff In Past Six Months
N
Foreign Worker Birth Country
TAIWAN
Class Of Admission
H-1B
Foreign Worker Education
Master's
Foreign Worker INFO Major
BIOMEDICAL ENGINEERING
Foreign Worker Education Completed
2019
Foreign Worker Educational Institution
THE GEORGE WASHINGTON UNIVERSITY
Foreign Worker Educational Institution Address 1
2121 I STREET NW
Foreign Worker Educational Institution City
WASHINGTON
Foreign Worker Educational Institution State
DC
Foreign Worker Educational Institution Country
UNITED STATES OF AMERICA
Foreign Worker Educational Institution Postal Code
20052
Foreign Worker Training Completed
N/A
Foreign Worker Has Required Work Experience
N/A
Foreign Worker Alternate Education/Experience
N/A
Foreign Worker Has Experience in Alternate Occupation
Y
Foreign Worker Experience With Employer
N
Employer Paid For Education
N
Foreign Worker Currently Employed
Y
Employer Completed Application
N
Preparer Name
Keith P Liston
Preparer Email
[email protected]
Name Of Person Signing Employer Declaration
Kathleen Ellwanger
Title of Person Signing Employer Declaration
Senior Paralegal
