IVD Director Full Time, Direct Hire San Diego, CA 92121 $180,000-220,000/yr

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We're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. We are more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

POSITION SUMMARY The Director, IVD will be responsible for developing and validating quantitative hematology, chemistry and immuno IVD assays. This position will lead or contribute to assay protocol development, design, execution and interpretation of validation studies and submission of analytical performance studies to the FDA. To be successful in the role, the individual must be detail-focused and have strong project management skills. The IVD Director will contribute to a collaborative workplace culture where we encourage honest and open communication and embrace agility while having fun. Our team members work with a sense of urgency and with a common goal of putting patients first. We prioritize transparency and continuous process improvement to contribute to the highest level of patient care.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to: Apply previous experience to obtain FDA clearance for hematology or chemistry IVD assays Organize and coordinate execution of multiple concurrent verification and validation studies, for submission to the FDA for 510(k) clearance Manage point of care and CLIA waiver studies Engage directly with FDA in support of regulatory communications Lead the drafting, review, and finalization of study protocols and reports Develop, mentor and grow team _____ Maintain compliance with all company policies, quality systems and procedures Perform other duties as requested

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES: Deep knowledge of CLSI standards Track record of successfully clearing quantitative assays Experience with point of care and waiver studies Deep knowledge and experience in hematology or chemistry IVDs Working knowledge of GMP, ISO 13485 quality systems, design verification and validation studies, and FDA regulations preferred Minimum Bachelor's Degree in biochemistry, chemistry, molecular biology or similar with 10 years of experience working on quantitative IVDs PhD strongly preferred