Fiscal Year

2021

Case Number

A-20270-04339

Case Status

Withdrawn

Received Date

2020-10-05

Decision Date

2020-11-20

Refile

N

Original File Date

2021-01-01 08:52:05

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

PROFUSA

Employer Name Slug

profusa

Employer Address 1

5959 Horton Street

Employer Address 2

Suite 450

Employer City

Emeryville

Employer City Slug

emeryville

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

95601

Employer Phone

4156559861

Employer Number of Employees

36

Employer Year Commenced Business

2009

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Bruce Smith

Employer Contact Address 1

5959 Horton Street

Employer Contact Address 2

Suite 450

Employer Contact City

Emeryville

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

95601

Employer Contact Phone

4156559861

Employer Contact Email

bruce.smith@profusa.com

Agent Attorney Name

Sharon M Dulberg

Agent Attorney Firm Name

McVey Mullery Dulberg

Agent Attorney Phone

(415) 781-1001

Agent Attorney Address 1

909 Montgomery Street

Agent Attorney Address 2

200

Agent Attorney City

San Francisco

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

94133

Agent Attorney Email

sdulberg@mmdlaw.net

PW Track Number

P10020009241272

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

200762.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-04-09

PW Expiration Date

2020-07-08

Wage Offer From

200762.00

Wage Offer To

0.00

Average Salary

200762.00

Wage Unit of Pay

Year

Worksite Address 1

5959 Horton Street

Worksite Address 2

Ste. 450

Worksite City

Emeryville

Worksite City Slug

emeryville

Worksite State

CALIFORNIA

Worksite Postal Code

94608

Job Title

Director, Regulatory Affairs

Job Title Slug

director-regulatory-affairs

Minimum Education

Master's

Major Field of Study

Biomedical Engineering

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 field

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

N

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Regulatory Affairs ManagerSpecialist

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

5 years of experience in medical device regulatory affairs 2 of the five years in supervisory experience, in regulatory affairs. Proven track record of direct experience in interfacing with the FDA, notified body NB, other health authorities. Strong knowledge of FDA, EU, Health Canada, and other applicable international regulatory requirements including clinical trial requirements, quality system requirements, submission requirements, labeling and promotion requirements. 5 years of regulatory affairs experience successfully working on Class II III devices submissions such as IDEs, 510k, PMA, Presubmissions, Technical File, and Design Dossiers. Experience in reviewing and supporting crossfunctional team on usability testing. Possess a broad knowledge of crossfunctional areas including Quality, Clinical Affairs, Manufacturing and Product Development. Excellent technical writing ability, verbal communication, listening, presentation, organizational and relationshipbuilding skills required. Effective planning and organization skills

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

2020-06-22

SWA Job Order End Date

2020-08-08

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2020-08-16

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-08-23

Employer Website From Date

2021-01-01 08:52:05

Employer Website To Date

2021-01-01 08:52:05

Professional Organization Ad From Date

2021-01-01 08:52:05

Professional Organization Advertisement To Date

2021-01-01 08:52:05

Job Search Website From Date

2020-08-13

Job Search Website To Date

2020-08-22

Employee Referral Program From Date

2021-01-01 08:52:05

Employee Referral Program To Date

2021-01-01 08:52:05

Local Ethnic Paper From Date

2020-08-19

Local Ethnic Paper To Date

2020-08-19

Radio/TV Ad From Date

2020-08-17

Radio/TV Ad To Date

2020-08-17

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

BIOMEDICAL ENGINEERING

Foreign Worker Years of Education Completed

2008

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

649 W 34TH ST, LOS ANGELES

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LOS ANGELES

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

90089

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Sharon M Dulberg

Preparer Title

Attorney

Preparer Email

sdulberg@mmdlaw.net

Employer Information Declaration Name

Bruce Smith

Employer Information Declaration Title

Chief of Staff