Regulatory Affairs Project Manager ( Medical Device) (RE-12450985) Texas, USA
| Salary: | Bonus |
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.)