Agent/ Attorney Address Line 1:1101 West Fulton Market
Agent/ Attorney Address Line 2:3rd Floor
Agent/ Attorney City:Chicago
Agent/ Attorney State/ Province:ILLINOIS
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:60607
Agent/ Attorney Email:kliston@hebf.com
Position Info
Prevailing Wage Track Number:P10021074146209
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Regulatory Affairs Specialists
Prevailing Wage Skill Level:Level II
Prevailing Wage:71864
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-08-12
Prevailing Wage Expiration Date :2022-06-30
Wage Offer From:90000
Wage Offer To:110000
Wage Offer Unit of Pay:Year
Workstie Address Line 1:5050 Nathan Lane N
Worksite Address Line 2:
Worksite City :Plymouth
Worksite State:MINNESOTA
Worksite Postal Code:55442
Job Title:Senior Regulatory Affairs Specialist
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Biomedical/Mechanical Engineering
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :N
Required Expreience Months :
Accept Alternate Field of Study:Y
Accept Alternate Major:Med Devices, PharmaPharmaco, Regulatory AffairsSci or rtld regulatoryeng sci fld. See H.14.
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Bachelor's
Other Alternate Level of Education:
Acceptable Years of Experience:5
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:12
Accept Alternate Job Title:Project Manager, Technical Manager, Regulatory Affairs Specialist, or related positions.
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:Masters or foreign equivalent degree in BiomedicalMechanical Engineering, Medical Devices, PharmacyPharmacology, Regulatory AffairsSciences, or in a closely related regulatoryengineering sciences field of study Will accept a Bachelors degree 5 years of progressive professional experience in lieu of a Masters degree each alternative requirement with at least 1 year of experience in i regulatory input and project management to medical device product lifecycle planning, product testing protocols, reports, and product approval regulatory strategies; ii preparing regulatory submissions, maintain regulatory files for product registrations and product renewals, and ensure regulatory compliance for medical devices pursuant to EU MDR, FDA 21 CFR Parts 801 820, GMP, ISO13485, and international regulatory requirements; iii maintaining product dossiers and EU technical files; iv preparing and submitting PMA, 510k, IDE, and engineering change orders; and v assessing regulatory implications for device changes, determining trade issues to anticipate regulatory obstacles, and supporting design review, design change and design transfer through product lifecycle. Employer will accept any suitable combination of education, training, or experience.
Combination Occupation :N
Offered to Applied Foreign Worker:Y
ForeignWorker Live on Premises :N
Live in Domestic Service Worker:N
Employment Contract :
Professional Occupation :Y
College/ University Teacher:N
Competitive Process:
Basic Recruitment Process :
Teacher Select Date:
Teacher Publish Journal Name:
Additional Recruitment Information:
Job Oder Start Date:2021-08-19
Job Oder End Date:2021-09-20
Sunday Edition Newspaper:Y
First Newspaper Name:The Minneapolis StarTribune
First Advertisement Start Date:2021-08-22
Second Newspaper Name:The Minneapolis StarTribune
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-08-29
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:
Employer Website to Date:
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-09-14
Job Search Website to Date:2021-09-28
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:2021-09-13
Employee Referral Program to Date:2021-09-27
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-08-25
Local Ethnic Newspaper to Date:2021-08-31
Radio/TV Ad from Date:
Radio/TV Ad to Date:
Employer Received the Payment:N
Payment Details:
Bargaining Representative Notified:N/A
Posted Notice at Worksite:Y
Layoff in Past Six Months:N
US Worker Considered:
Country of Citizenship:INDIA
Foreign Worker Birth Country:INDIA
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Bachelor's
Foreign Worker Education Other:
Foreign Worker Major:MECHANICAL ENGINEERING
Year of Compelted Education:2010
Foreign Worker Istitution of Eduation:JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY
