Director of Operations & Regulatory Compliance

Director of Operations & Regulatory ComplianceLocation: Atlanta, GACompany: Thrive 365 LabsAbout Thrive 365 LabsThrive 365 Labs is a rapidly growing healthcare diagnostics company helping physicians and laboratories deliver faster, more accurate testing. Our mission is to elevate the standard of care by combining innovative diagnostic technology with operational excellence and unmatched support. We serve practices and laboratories nationwide, empowering clinicians to provide precision-driven results and improve patient outcomes.Role OverviewThe Director of Operations & Regulatory Compliance leads equipment deployment, lab readiness, documentation, and cross-functional project execution. This person ensures that processes are followed consistently and that internal quality and regulatory documentation is complete and organized.This role also contributes to internal development work where method development or feasibility studies may be performed (e.g., LDT-related projects) in a controlled and documented manner.ResponsibilitiesOperational Execution•⁠  ⁠Lead onsite implementation and setup related to new lab equipment placements.•⁠  ⁠Coordinate project planning, logistics, scheduling, and stakeholder alignment.•⁠  ⁠Ensure readiness of lab infrastructure, workflows, and supporting documentation.Quality & Regulatory Documentation•⁠  ⁠Own internal QMS documentation: SOPs, training, version control, deviation/CAPA tracking.•⁠  ⁠Create repeatable templates and documentation used across deployments.•⁠  ⁠Maintain organized and audit-ready documentation.Support Internal Development Projects (including LDT)•⁠  ⁠Participate in internal method development, feasibility, or exploratory testing work.•⁠  ⁠Assist with data organization, documentation, and structured recordkeeping.•⁠  ⁠Follow internal procedures for controlled study documentation and data handling.Regulatory Coordination•⁠  ⁠Assist with preparation and organization of documentation for regulatory pathways or submissions.•⁠  ⁠Compile supporting technical files and maintain document traceability.Cross-functional Collaboration•⁠  ⁠Collaborate with operations, supply chain, install teams, sales support, and client stakeholders.•⁠  ⁠Serve as a technical documentation and project execution point of contact.•⁠  ⁠Act as primary technical/regulatory liaison for client lab directors.Required Experience•⁠  ⁠Experience in a regulated laboratory, diagnostics, medical device, IVD, or biotech environment•⁠  ⁠Experience with quality system documentation (SOPs, version control, QMS, CAPA, training logs)•⁠  ⁠Experience supporting regulated documentation or regulatory submission preparation (e.g., FDA/FDA-pathway documentation, technical file compilation, 510(k) familiarity)•⁠  ⁠Strong project execution skills — ability to own a deployment from planning → completion•⁠  ⁠Willing to travel to sites (approx. 25–40%)Preferred Experience•⁠  ⁠Experience supporting method development, feasibility, or LDT-related projects•⁠  ⁠Exposure to or involvement in regulatory documentation pathways (e.g., FDA, 510(k), CLIA, ISO, QMS environments)•⁠  ⁠Familiarity working with chemistry analyzers or comparable systems. Compensation & Benefits•⁠  ⁠Competitive salary•⁠  ⁠Performance-based milestone bonus•⁠  ⁠Health, dental, vision benefits•⁠  ⁠Equity opportunity