Agent/ Attorney Firm Name:Fragomen, Del Rey, Bernsen Loewy, LLP
Agent/ Attorney Phone:408-919-0600
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:2755 Orchard Parkway
Agent/ Attorney Address Line 2:
Agent/ Attorney City:San Jose
Agent/ Attorney State/ Province:CALIFORNIA
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:95134
Agent/ Attorney Email:philips@fragomen.com
Position Info
Prevailing Wage Track Number:P10020280861387
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Regulatory Affairs Specialists
Prevailing Wage Skill Level:Level II
Prevailing Wage:57803
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-03-05
Prevailing Wage Expiration Date :2021-06-30
Wage Offer From:97204
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:22100 Everett Highway
Worksite Address Line 2:
Worksite City :Bothell
Worksite State:WASHINGTON
Worksite Postal Code:98021
Job Title:Regulatory Affairs Specialist
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Biomedical Regulatory Affairs
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :12
Accept Alternate Field of Study:Y
Accept Alternate Major:Life sciences or related 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:12
Accept Alternate Job Title:In job offered, or as a Medical Device Quality Engineer, or related occupation
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:Experience with or knowledge of the following can be gained concurrently with required experience andor through education Medical device registration requirements such as CE Mark, 510k, Premarket Approval PMA, Design Dossier; International medical device quality system and design requirements such as ISO 13485, ISO 14971, and IEC 62304; Data standards and advertisingpromotion regulatory minimums to market medical devices internationally; Identification of all necessary registration forms, materials, and application fee processes for medical device registrations; Revising creating new technical files under the MDDMDR to compliantly market medical devise in Europe.