Regulatory Affairs SME (Obsolescence)

Boston, MA

Job ID: 122972 Industry: Med

Medical Device Reg Affairs Specialist (Obsolescence)

Environment:

Our client is a large medical device manufacturer. They manufacturing several class 2 and 3 medical devices. They need a Regulatory Affairs consultant to come in and help with obsolescence and RA change management.

Principle Duties and Responsibilities:

The consultant will be from the medical device industry, and will have done submissions and change management for RA submissions.   The consultant should be familiar with intended use, and how to update submissions/tech files as the client changes their products.  The changes include, process changes to manufacturing/development, site transfers, and obsolescence.  

If the consultant has experience with RA for orthopedics that would be a huge plus.

Required:
  • Medical Device 
  • Reg Affairs
  • Reg Affairs change management
  • Tech file updates
  • Obsolescence

 

Plus:

-           Orthopedic Implants

Job Type: Contract 

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