All Details of Green Card Application:
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Case Number: A-23024-92234
Fiscal year: 2024
Fiscal Year
2024
Case Number
A-23024-92234
Case Status
Certified-Expired
Received Date
2023-03-09
Decision Date
2024-03-29
Refile
N
Original File Date
2024-01-01 01:04:29
Previous SWA Case Number State
Schedule A Sheepherder
N
Employer Name
MEDTRONIC, INC.
Employer Name Slug
medtronic-inc
Employer Address 1
710 MEDTRONIC PARKWAY
Employer Address 2
Employer City
MINNEAPOLIS
Employer City Slug
minneapolis
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
34100
Employer Year Commenced Business
1949
NAICS Code
334510
FW Ownership Interest
N
Employer Contact Name
Lisa M Pedrys
Employer Contact Address 1
710 Medtronic Parkway
Employer Contact Address 2
Employer Contact City
Minneapolis
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
Zhu Cheng
Agent Attorney Firm Name
Fredrikson Byron, P.A.
Agent Attorney Phone
6124927399
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
55402
Agent Attorney Email
zcheng@fredlaw.com
PW Track Number
P10022062947889
PW SOC Code
11-9199.01
PW SOC Title
Regulatory Affairs Managers
PW Skill Level
Level IV
PW Wage
176696.00
PW Unit of Pay
Year
PW Wage Source
OES
PW Determination Date
2022-09-04
PW Expiration Date
2023-06-30
Wage Offer From
176700.00
Wage Offer To
0.00
Average Salary
176700.00
Wage Unit of Pay
Year
Worksite Address 1
3880 Brickway Blvd
Worksite Address 2
Worksite City
Santa Rosa
Worksite City Slug
santa-rosa
Worksite State
CALIFORNIA
Worksite Postal Code
95403
Job Title
Regulatory Affairs Manager
Job Title Slug
regulatory-affairs-manager
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
Biomedical Engineering or related technical 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 specialist or related occupation in regulatory affairs in the medical device fld.
Job Opportunity Requirements Normal
Y
Foreign Language Required
N
Specific Skills
Requires a Masters degree in Regulatory Affairs, Biomedical Engineering, or related technical field and 3 years of experience as a regulatory affairs specialist or related occupation in regulatory affairs in the medical device field, or Bachelors degree in Regulatory Affairs, Biomedical Engineering, or related technical field and 5 years of experience as a regulatory affairs specialist or related occupation in regulatory affairs in the medical device field.br br Must possess 3 years of experience in each the followingbr br Developing regulatory strategies for approval in US, EU, Japan, Australia, China, and Canadabr Regulatory implications of post market manufacturing changesbr Preparing regulatory submissions for US Class III and Class II devices including IDE and IDE supplementsbr Preparing regulatory submissions EU Design Dossiers, Design Dossier Supplements and Technical Filesbr PreMarket Approval PMA applications, PMA Supplements, FDA presubmissions, Annual Reports, Post Approval study Reports, IDE Annual Progress Reports, 510ksbr Regulatory review of advertising and promotional materialsbr Global submissions including Japan Shonin, Health Canada new license or license amendment submissions, and China submissionsbr FDA Quality System Regulation QSR ISO 13485, ISO 14971, 21 CFR parts 807, 814, 820 and 821
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
2022-10-17
SWA Job Order End Date
2022-11-18
Sunday Edition Newspaper
Y
First Newspaper Name
The Press Democrat
First Advertisement Start Date
2022-10-23
Second Newspaper Ad Name
The Press Democrat
Second Advertisement Type
Newspaper
Second Ad Start Date
2022-10-30
Employer Website From Date
2022-10-17
Employer Website To Date
2022-12-17
Professional Organization Ad From Date
2024-01-01 01:04:29
Professional Organization Advertisement To Date
2024-01-01 01:04:29
Job Search Website From Date
2024-01-01 01:04:29
Job Search Website To Date
2024-01-01 01:04:29
Employee Referral Program From Date
2022-10-18
Employee Referral Program To Date
2022-11-01
Local Ethnic Paper From Date
2022-10-28
Local Ethnic Paper To Date
2022-11-03
Radio/TV Ad From Date
2024-01-01 01:04:29
Radio/TV Ad To Date
2024-01-01 01:04:29
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
700 NORTHERN BOULEVARD
Foreign Worker Education Institution Address 2
Foreign Worker Education Institution City
BROOKVILLE
Foreign Worker Education Institution State/Province
NY
Foreign Worker Education Institution Country
UNITED STATES OF AMERICA
Foreign Worker Education Institution Postal Code
11548
Foreign Worker Experience with Employer
N
Foreign Worker Employer Pays for Education
N
Foreign Worker Currently Employed
Y
Employer Completed Application
N
Preparer Name
Zhu Cheng
Preparer Title
Attorney
Preparer Email
zcheng@fredlaw.com
Employer Information Declaration Name
Lisa M Pedrys
Employer Information Declaration Title
Director, Medtronic Immigration Solutions Team