Laboratory Director (Medtech)

TL;DR

Laboratory Director (Medtech): Establishing and leading a new, FDA-regulated clinical laboratory with an accent on CLIA certification, method validation, and regulatory compliance. Focus on building the laboratory from the ground up, overseeing pivotal clinical studies for home-collection diagnostic systems, and transitioning to scaled routine operations.

Location: Must be based in or able to work on-site in South Plainfield, New Jersey

Salary: $210,000 – $240,000

Company

A leading health and wellness platform redefining healthcare by providing accessible, personalized, and affordable diagnostic and treatment solutions.

What you will do

• Obtain CLIA certification and secure necessary state laboratory licenses.
• Design the physical laboratory plant, including bench layout, sample flow, and biosafety controls.
• Serve as the CLIA Laboratory Director and license holder with full regulatory accountability.
• Lead method validation and verification for core assays to support FDA clearance.
• Oversee the integrity of pivotal clinical studies, including specimen management and chain of custody.
• Define the long-term operating model, including staffing, automation, and quality metrics.

Requirements

• Doctoral degree (MD, DO, or PhD) qualifying for CLIA high-complexity Laboratory Director status.
• Current board certification and eligibility to serve as a Laboratory Director.
• Licensed to serve as a laboratory director in New York and New Jersey.
• Demonstrated experience in high-complexity testing and clinical chemistry method validation.
• Working command of CLIA, CLSI standards, and FDA IVD requirements (21 CFR 820).
• Ability to defend laboratory processes and data during FDA inspections.

Nice to have

• Experience supporting FDA 510(k) or PMA submissions.
• Domain depth in HbA1c testing methodologies.
• Familiarity with capillary and self-collected specimen pre-analytic considerations.

Culture & Benefits

• Comprehensive health benefits including medical, dental, and vision.
• 401k retirement plan with employer matching.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Employee Stock Purchase Program (ESPP) and equity grants.
• Flexible, talent-first work environment with team retreats.