Our client is seeking a Director of Regulatory Affairs and Quality Assurance. The appropriate candidate will be an expert in FDA compliance (CE IVD, FDA 510K, etc.) and ISO regulatory standards (Specifically 9001 & 13485). Furthermore, this role will be responsible for developing, negotiating, and executing regulatory strategies. The Director of Regulatory Affairs and Quality Assurance will develop and lead the quality strategy for the company on a global scale, to include their ISO 9001/13485 based programs. This role would have multiple direct reports and simultaneously report directly to the CEO.
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