Advance your career in beautiful San Diego! A Top-Tier Global Life Sciences Leader is seeking a Regulatory Affairs Specialist III for a hybrid role (3 days onsite). This position offers an exciting opportunity to independently lead regulatory strategies for high-scrutiny In-Vitro Diagnostic (IVD) blood-screening product lines, collaborating closely with R&D to bring next-generation testing technologies to the global market. Prior experience i[ "\r\n\t\r\n\t. Prepare and file complex pre-market and post-market regulatory submissions with the US FDA, EU Notified Bodies, and other international authorities.\r\n\t\r\n\t\r\n\t. Develop and execute global submission strategies for high-risk in vitro diagnostic (IVD) products from concept to commercialization.\r\n\t\r\n\t\r\n\t. Partner with R&D and cross-functional teams to translate complex technical and scientific data into comprehensive regulatory documentation.\r\n\t\r\n\t\r\n\t. Independently manage correspondence with health agencies, authoring clear and timely responses to inquiries.\r\n\t\r\n\r\n" ][ "Education\r\n\r\n. Bachelor's Degree required in the life sciences, engineering or similarly related field\r\n\r\n. Experience\r\n\r\n 6 years of experience in a regulated environment with 4 years direct experience in Regulatory Affairs. IVD or Biologics Industry experience required\r\n\r\n. Minimum 4 years experience in Reg Affairs supporting highly regulated IVD products (CBER-regulated BL - As, Class D for EU IVDR) or non-device BL - As as long as they are above Class I / Class A.\r\n" ]

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