Agent/ Attorney Address Line 1:200 South Sixth Street
Agent/ Attorney Address Line 2:Suite 4000
Agent/ Attorney City:Minneapolis
Agent/ Attorney State/ Province:MINNESOTA
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:550421425
Agent/ Attorney Email:lhuynh@fredlaw.com
Position Info
Prevailing Wage Track Number:P10021032045027
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Regulatory Affairs Specialists
Prevailing Wage Skill Level:Level III
Prevailing Wage:79560
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-06-15
Prevailing Wage Expiration Date :2021-09-13
Wage Offer From:80000
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:2300 Berkshire Lane
Worksite Address Line 2:Suite 5
Worksite City :Plymouth
Worksite State:MINNESOTA
Worksite Postal Code:55441
Job Title:Regulatory Affairs Specialist
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Regulatory Affairs
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:Biomedical Engineering, or related medicalscientific field
Alternate Combination of Education/ Experience:N
Required Alternate Level of Education :
Other Alternate Level of Education:
Acceptable Years of Experience:
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:6
Accept Alternate Job Title:experience in regulatory affairs
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:Requires a Masters degree in Regulatory Affairs, Biomedical Engineering, or related medicalscientific field and six 6 months of experience in regulatory affairs. Must possess a minimum of six 6 months with each of the following Class II and Class III medical devices; medical device submissions and clearances including FDA medical device regulations and EU Medical Device Directive 200747EC; product changes, design changes, manufacturing changes, supplier changes, labeling changes, product registrations and audits; developing regulatory strategies, timelines, and deliverables for approval in U.S. and EU for medical devices or combination products; 510k, IDE and PMA device product submissions; ISO 13485 and ISO 14971; technical literature to include labeling, IFUs, manuals, patient guides, clinical literature and advertising promotion materials; and review, approval, and coordination of changes associated with product and process in electronic document control systems.
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:2021-07-19
Job Oder End Date:2021-08-19
Sunday Edition Newspaper:Y
First Newspaper Name:Star Tribune
First Advertisement Start Date:2021-07-25
Second Newspaper Name:Star Tribune
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-08-01
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-07-19
Employer Website to Date:2021-09-20
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:
Job Search Website to Date:
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:2021-07-19
Employee Referral Program to Date:2021-08-02
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-07-29
Local Ethnic Newspaper to Date:2021-08-04
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:Master's
Foreign Worker Education Other:
Foreign Worker Major:REGULATORY AFFAIRS
Year of Compelted Education:2018
Foreign Worker Istitution of Eduation:NORTHEASTERN UNIVERSITY
Foreign Worker Education Instution Address Line 1:360 HUNTINGTON AVE
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:BOSTON
Foreign Worker Educatution Institution State:MA
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:2115
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N/A
Foreign Worker Alternate Education and Experience :N/A
Foreign Worker Alternate Occupation Experience:Y
Foreign Worker Experience with Employer:N
Foreign Worker Employer Pay 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 Declaration Title:Director, Medtronic Immigration Solutions Team
