RA SPECIALIST

JOB PURPOSE AND SCOPE  
· Responsible for the coordination and preparation of document packages for regulatory submissions.  
· Monitors and improves tracking/control systems.  
· Keeps abreast of regulatory procedures and changes.  
· May direct interaction with regulatory agencies on defined matters.  
· Ensures rapid and timely approval on medical devices and continued approved status of marketed medical devices.  
· Ensures compliance with regulations and interpretations 
CORE JOB RESPONSIBILITIES  
· Compiles all materials required in submissions and license renewal.  
· Coordinates and maintains reporting schedules for product licensing application notices.  
· Interacts with regulatory agency personnel in order to expedite approval of pending applications. 
· Compliance Work, procedures, employee trainings, promo materials, registration/approval etc. 
  
MINIMUM SKILLS REQUIRED  
· BSc Science/Engineering degree or higher 
· At least 3 years prior experience related to regulatory affairs in a medical device company  
· Working knowledge of the FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971 and the Medical Device Regulation MDR. And MDSAP program  
· Organized with a high attention to detail 
· Skill to conduct multiple tasks at the same time 
· Communication skills 
· Demonstrated scientific analysis abilities 
· Excellent spoken and written of English and local language 
· Job is Open for both man and women.