Remote Medical Device Sr. Regulatory Affairs SME

Edison, NJ

Job ID: 122776 Industry: Med

Remote Medical Device Sr. Regulatory Affairs SME

Project Description:

Our client is a Medical Device and Pharmaceutical organization currently seeking a high-level Regulatory Affairs subject matter expert to provide expertise on Regulatory Strategy, FDA correspondence, and Regulatory Submissions consultation for a combination device. The client’ s internal personnel is generally very well-versed in Regulatory Affairs for Pharmaceuticals, but they seek a true consultant with extensive Regulatory experience on the Medical Device side. This individual must also have a strong regulatory background in combination devices. The combo device itself is considered somewhat complex, so the client seeks a candidate with experience working with non-traditional combo products.

Responsibilities:

This Sr. Regulatory Affairs SME will be responsible for helping the Regulatory team with Regulatory Submissions Strategy, Pre-Submissions, and FDA Correspondence. The client is currently deciding upon a few different injector products for the device, and this individual will likely start by helping to drive this process from an RA standpoint (ensuring potential suppliers devices’ products meet FDA compliance standards). They will be expected to counsel the team on Regulatory Strategy and how to successfully communicate with the FDA. The client’ s headquarters are located in Switzerland, so it is important that this individual has experience working with European companies and understands the cultural differences when doing business with EU organizations. This individual must have strong communication skills and th

Required Skills:
  • Medical Devices
  • Combination Devices
  • Regulatory Affairs
  • Regulatory Strategy
  • FDA Correspondence

Plus
  • Non-traditional/Complex Combo Devices

Job Type: Contract  

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