Regulatory Affairs Project Manager ( Medical Device)
Real - Texas

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Title:
Regulatory Affairs Manager ( Medical Device)

Role:
Reporting to the Senior Director of Regulatory Affairs, you will plan, organize, and submit RA submissions in a timely manner, and be responsible for much of the overall regulatory requirements for this Class II & Class III device company. This is an extremely exciting opportunity offering a competitive salary as well as generous benefits.

Responsibilities:
  • Prepares and reviews 510k submissions
  • Evaluate changes to regulatory documents and recommend appropriate filing category
  • Represent Regulatory Affairs on innovation teams
  • Reviews regulatory and related publications to assure compliance and anticipate future regulatory action
  • Coordinate compilation and reviews CMC data package for appropriate and complete documentation
  • Interacts with RA colleagues world-wide
  • Understanding of CMC
  • Analyze regulatory information by determining acceptability of data, procedures, and other product-related documentation
Requirements:
  • Minimum of BS degree in life sciences or related field, ideally an MS or advanced degree in chemistry or related scientific field
  • Minimum 6 years in pharmaceutical regulatory affairs, with an emphasis on generics and RA strategy
  • Ability to work independently and on teams
  • Prior experience interacting with the FDA in the Medical Device industry
  • A strong analytic background and chemistry knowledge.
  • Strong computer skills in Word, Excel ; RAPS RAC (U.S.)To find out more about Real please visit www.realstaffing.com

Real - 17 months ago - save job - block
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