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Indotronix Avani Group
Project Manager
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Project Manager at Indotronix Avani Group Project Manager at Indotronix Avani Group in Del Mar, California Posted in 22 days ago.
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full-time The Project Manager will lead cross-functional initiatives focused on technical dossier audits and regulatory readiness activities for in-market clinical diagnostic products Bachelor's degree in a scientific, engineering, regulatory, or related discipline. Minimum of 3-5 years of experience in project management within a regulated industry. Experience working in medical devices, in vitro diagnostics (IVD), biotechnology, life sciences, or related regulated environments. Demonstrated experience leading cross-functional initiatives involving multiple stakeholders and competing priorities. Working knowledge of product development documentation, design controls, quality systems, and regulatory submission processes. Experience coordinating complex projects involving documentation review, compliance assessments, or remediation activities preferred. Familiarity with global regulatory frameworks applicable to medical devices and IVD products is preferred. Experience supporting regulatory submissions, product registrations, or compliance programs is a plus. Project Management Professional (PMP) certification is a plus but not required.