Regulatory Affairs Specialist
MicroAire Surgical Instruments
MicroAire Surgical Instruments is seeking a Regulatory Affairs Specialist – OUS (Outside United States) to provide direction regarding regulatory matters and submission strategies for New Product Development (Innovation) for International Product Registrations, with the exception of EU countries and Canada.
MicroAire Surgical Instruments, LLC. is a fast-growing medical device company seeking a General Accounting Assistant that is interested in taking their abilities to the next level. 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. MicroAire is able to both provide a small company experience that will allow you to see your personal impact on the organization while having the financial security of the company Forbes magazine ranks as the largest in the world (Forbes, May 12, 2022).
- Evaluate registration requirements and create, process, and submit associated documentation in order to register products internationally (or to maintain registration)
- Work with Distributors, Regulatory Agencies, Regulatory Bodies, and Ministries of Health in order to ensure Regulatory Compliance and support registration
- Maintain MicroAire’s Internal departments: (1) Business Development (which should be considered a dotted line responsibility for priorities), and (2) Corporate Compliance (for Distributor contracts and trade requirements)
Experience and Qualifications
- Bachelor’s Degree in related field OR equivalent experience
- 5+ years of applicable OUS Medical Device registration experience required
- Paid Holidays
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