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.)