All Details of Green Card Application:
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Case Number: A-22123-49860
Fiscal year: 2023
Fiscal Year
2023
Case Number
A-22123-49860
Case Status
Certified
Received Date
2022-05-31
Decision Date
2023-01-27
Refile
N
Original File Date
2023-01-01 08:10:43
Previous SWA Case Number State
Schedule A Sheepherder
N
Employer Name
COVIDIEN
Employer Name Slug
covidien
Employer Address 1
A MEDTRONIC COMPANY
Employer Address 2
710 MEDTRONIC PARKWAY LC300
Employer City
FRIDLEY
Employer City Slug
fridley
Employer State
MINNESOTA
Employer State Slug
minnesota
Employer Country
UNITED STATES OF AMERICA
Employer Postal Code
55432
Employer Phone
763-505-2710
Employer Number of Employees
7647
Employer Year Commenced Business
1960
NAICS Code
339112
FW Ownership Interest
N
Employer Contact Name
Lisa M Pedrys
Employer Contact Address 1
710 Medtronic Parkway NE, LC300
Employer Contact Address 2
Employer Contact City
Fridley
Employer Contact State/Province
MINNESOTA
Employer Contact Country
UNITED STATES OF AMERICA
Employer Contact Postal Code
55432
Employer Contact Phone
763-505-2710
Employer Contact Email
Lisa.Marie.Pedrys@Medtronic.com
Agent Attorney Name
Loan T Huynh
Agent Attorney Firm Name
Fredrikson Byron PA
Agent Attorney Phone
6124927165
Agent Attorney Address 1
200 South Sixth Street
Agent Attorney Address 2
Suite 4000
Agent Attorney City
Minneapolis
Agent Attorney State/Province
MINNESOTA
Agent Attorney Country
UNITED STATES OF AMERICA
Agent Attorney Postal Code
554021425
Agent Attorney Email
lhuynh@fredlaw.com
PW Track Number
P10021154366502
PW SOC Code
13-1041
PW SOC Title
Regulatory Affairs Specialists
PW Skill Level
Level IV
PW Wage
99133.00
PW Unit of Pay
Year
PW Wage Source
OES
PW Determination Date
2021-11-10
PW Expiration Date
2022-06-30
Wage Offer From
99200.00
Wage Offer To
0.00
Average Salary
99200.00
Wage Unit of Pay
Year
Worksite Address 1
5290 California Ave
Worksite Address 2
Worksite City
Irvine
Worksite City Slug
irvine
Worksite State
CALIFORNIA
Worksite Postal Code
92617
Job Title
Sr. Regulatory Affairs Specialist
Job Title Slug
sr-regulatory-affairs-specialist
Minimum Education
Bachelor'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
Biomedical Engineering, or Medical Device and Diagnostic Engineering
Accept Alternative Combination
Y
Accept Alternative Combination Education
Master's
Accept Alternative Combination Education Years
2
Accept Foreign Education
Y
Accept Alternative Occupation
Y
Accept Alternative Occupation Months
60
Accept Alternative Job Title
Experience in Regulatory Affairs
Job Opportunity Requirements Normal
Y
Foreign Language Required
N
Specific Skills
Must possess a Masters degree in Regulatory Affairs, Biomedical Engineering, or Medical Device and Diagnostic Engineering and two 2 years of experience in Regulatory Affairs; or Bachelors in Regulatory Affairs, Biomedical Engineering, or Medical Device and Diagnostic Engineering and five 5 years of experience in Regulatory Affairs.br br Must possess at least two 2 years of experience with the followingbr br Authoring US submissions for Class II medical devices;br Authoring design dossiers, technical files and change notifications for EU class IIII medical devices;br Labeling andor promotional material review for US Class II medical devices;br Regulatory input into design control, manufacturing, marketing, promotion, labeling and clinical for pre and postmarket activity for Class III and Class II medical devices in the EU and Class II in the US;br MDDMDR, Food Drug and Cosmetic Act, ISO 14971 and ISO 13485; andbr Regulatory support for product lifecycle processes to include preclinical, clinical, approval, postapproval and obsolescence.
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
2021-12-10
SWA Job Order End Date
2022-01-10
Sunday Edition Newspaper
Y
First Newspaper Name
Los Angeles Times
First Advertisement Start Date
2021-12-12
Second Newspaper Ad Name
Los Angeles Times
Second Advertisement Type
Newspaper
Second Ad Start Date
2021-12-19
Employer Website From Date
2021-12-06
Employer Website To Date
2022-02-11
Professional Organization Ad From Date
2023-01-01 08:10:43
Professional Organization Advertisement To Date
2023-01-01 08:10:43
Job Search Website From Date
2023-01-01 08:10:43
Job Search Website To Date
2023-01-01 08:10:43
Employee Referral Program From Date
2021-12-06
Employee Referral Program To Date
2021-12-20
Local Ethnic Paper From Date
2021-12-15
Local Ethnic Paper To Date
2021-12-15
Radio/TV Ad From Date
2023-01-01 08:10:43
Radio/TV Ad To Date
2023-01-01 08:10:43
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
Loan T Huynh
Preparer Title
Attorney
Preparer Email
lhuynh@fredlaw.com
Employer Information Declaration Name
Lisa M Pedrys
Employer Information Declaration Title
Director, Medtronic Immigration Solutions Team