
Regulatory Affairs Lead — IVD/NGS Submissions (Contract)
Katalyst CRO, Charlotte, NC, United States
A leading pharmaceutical company in Charlotte, NC, is seeking a Regulatory Affairs Manager to lead regulatory guidance and ensure compliance with U.S. and global regulations. The ideal candidate holds a B.Sc. in a relevant field with over 5 years in IVD Regulatory Affairs, possesses hands-on experience with submission processes such as 510(k) and PMA, and is adept in regulatory strategy development. This contract role offers an engaging environment with responsibilities across various regulatory tasks.
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