MicroAire Surgical Instruments, LLC. is a fast-growing medical device company seeking a Senior Regulatory Affairs Specialist with experience with 510(k) and EU/Notified Body submissions.  MicroAire is one of four companies within Colson Medical, LLC., the medical group of Marmon Holdings, Inc., under Berkshire Hathaway, Inc., a Fortune 100 company.  SUMMARY The Sr. Regulatory Affairs Specialist is responsible for: (1) providing direction in regulatory compliance matters  and submission strategies to New Product Development (Innovation), (2) supporting timely domestic, EU, and othe