Agent/ Attorney Address Line 1:200 South Sixth Street, Suite 4000
Agent/ Attorney Address Line 2:
Agent/ Attorney City:Minneapolis
Agent/ Attorney State/ Province:MINNESOTA
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:55402
Agent/ Attorney Email:lhuynh@fredlaw.com
Position Info
Prevailing Wage Track Number:P10021197468189
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Compliance Officers
Prevailing Wage Skill Level:Level III
Prevailing Wage:88608
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-12-22
Prevailing Wage Expiration Date :2022-06-30
Wage Offer From:104000
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:15 Hampshire Street
Worksite Address Line 2:
Worksite City :Mansfield
Worksite State:MASSACHUSETTS
Worksite Postal Code:2048
Job Title:Sr. 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 a closely related technical field
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Bachelor's
Other Alternate Level of Education:
Acceptable Years of Experience:4
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:24
Accept Alternate Job Title:experience with Regulatory Affairs for Class II and Class III medical devices
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:Requires a Masters degree in Regulatory Affairs or Biomedical Engineering, or a closely related technical field, and two 2 years of experience with Regulatory Affairs for Class II and Class III medical devices; OR alternatively, Bachelors degree in Regulatory Affairs or Biomedical Engineering, or a closely related technical field, and four 4 years of experience with Regulatory Affairs for Class II and Class III medical devices. Must possess a minimum of two 2 years of experience with each of the following 510k submissions; EU design dossiers, technical files, and change notifications; InSight and Agile systems; change assessment for device changes for regulatory implications; development and implementation of standard operating procedures for regulatory affairs activities; 21 CFR Parts 11, 50, 54, 56, 803, 806, 807, 812 and 814; and 21 CFR 820, ISO13485, and ISO14971. Position is open to telecommuting from anywhere in the U.S.
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:2021-09-27
Job Oder End Date:2021-10-28
Sunday Edition Newspaper:Y
First Newspaper Name:Boston Globe
First Advertisement Start Date:2021-10-03
Second Newspaper Name:Boston Globe
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-10-10
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-09-27
Employer Website to Date:2021-11-28
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:2021-09-27
Employee Referral Program to Date:2021-10-12
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-10-07
Local Ethnic Newspaper to Date:2021-10-07
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:2015
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
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
