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Title : JA- Regulatory Affairs Specialist -442
State : Florida   Date : Mar 13, 2019
Experience Level :  
Position Type : Regulatory Affairs Specialist      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Jacksonville, FL


Job Title: Regulatory Affairs Specialist


Duration:  5+ months (extendable) contract on W2


Duties:


This position is an entry to mid-level professional position in a Regulatory Affairs group, supporting implementation and compliance with the EU Medical Device Regulations. Primary responsibilities include support and assistance in preparation, submission, and maintenance of global regulatory documents/dossiers under direct supervision. Prepares, compiles and submits global regulatory dossiers, US and International for new and existing products. Complete Regulatory Impact assessments for product, process and package changes and communicate results to the appropriate departments. Coordinate and assist in the maintenance of licenses and authorizations for existing products (e.g., US PMA, International Registrations and Dossiers, updates to technical files), engineering and device changes requests. Participates in cross-functional project teams. Coordinates and assists in the review and approval of new and/or revised product labeling to ensure regulatory compliance. Provides Regulatory Affairs support during internal and external audits (as needed). Update Regulatory Affairs procedures as needed to comply with EU MDR Requirements.



Skills:


One to three years of experience.


Education:


BS degree (scientific discipline preferred) or equivalent



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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Princeton , NJ 08540 
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