Job Description

About MetaOptima:
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Join MetaOptima to make a difference in the lives of millions as we revolutionize the dermatology industry with software, hardware and AI for faster, more effective, and affordable care. MetaOptima is full of passionate, innovative people who thrive on working together as a team to build smart, life-saving technologies for medical professionals and their patients. Our casual, open-office culture welcomes fresh ideas from the minds of doers. Join us to add your voice to our vision while working with a cool group of people set on making their mark on the world. We take pride in what we've accomplished together, and can't wait to see how you'll help us grow.Job Summary:
We're looking for a hands-on program manager to drive the clinical-and-regulatory workstream that gets our AI decision-support for dermatology through regulatory clearance. You'll sit at the intersection of clinical research, regulatory strategy, quality, and engineering, coordinating clinicians, statisticians, external consultants, and MetaOptima leadership to deliver a submission that stands up to scrutiny.
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Qualifications & Skills:
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5+ years in clinical or regulatory program management for SaMD, AIaMD, or medical imaging devices. Track record with SaMD or AI-enabled software in healthcare, including direct contribution to at least one successful FDA submission (e.g., 510(k) or De Novo). Hands-on authorship of protocols, SOPs, IRB submissions, and study documentation - comfortable owning first drafts and redlines. Practical understanding of GCP, ISO 14971, IEC 62304, 21 CFR Part 11, and data-privacy basics (HIPAA; GDPR awareness). Ability to translate between clinical, regulatory, and engineering worlds; clear written and verbal communication with senior and technical stakeholders. Working literacy in AI/ML performance concepts (dataset splits, sensitivity/specificity, ROC/AUC, calibration, drift) and how they map to claims. Strong program management: critical path planning, RAID (risks/assumptions/issues/dependencies), and vendor management.
### Preferred Qualifications:

Bachelor's degree in life sciences, biomedical engineering, or related discipline; advanced degree preferred. Dermatology, digital imaging, or reader-study experience (e.g., multi-reader multi-case (MRMC) designs). Experience with Pre-Sub strategy, SPS/ACP, or the FDA TAP/STeP programs. Exposure to other regions (EU MDR, UKCA, Australia TGA, New Zealand Medsafe). Knowledge of statistical analysis for power calculations Familiarity with human-factors/usability files and labeling (IFU, indications/contraindications).
### Responsibilities:

Clinical study design & execution: Draft and iterate the protocol, informed consent, case report forms (CRFs), site manuals, and monitoring plan; align with GCP and ISO 14155. Ethics & sites: Prepare and submit IRB packages, manage multi-site start-up, conduct site training, track deviations/adverse events, and keep enrollment on plan. Regulatory pathway & interactions: Build the submission plan for 510(k) or De Novo (as appropriate); prepare Q-Sub (Pre-Submission) materials and lead FDA meetings; document decisions and follow-ups. AI/Software documentation: Coordinate evidence for SaMD and AIaMD: intended use, dataset curation, reference standards, performance claims (sensitivity/specificity, ROC/AUC), generalization and bias checks, and Good Machine Learning Practice (GMLP) rationale. SPS/ACP readiness: Contribute to SaMD Pre-Specification (SPS) and Algorithm Change Protocol (ACP) concepts where relevant. Quality & risk integration: Maintain study-related SOPs (Standard Operating Procedures), contribute to Design History File (DHF) items, and support ISO 14971 risk management and IEC 62304 software lifecycle evidence. Data & tools: Oversee data management (EDC such as REDCap), query handling, audit trails (21 CFR Part 11), privacy (HIPAA, with awareness of GDPR/PIPEDA for global work). Vendor/consultant orchestration: Scope and manage CROs/biostats/regulatory consultants; drive clear SOWs, timelines, and deliverables. Stakeholder communication: Run a transparent cadence with the CTO, CEO, engineering/ML team, clinicians, and statistician; publish crisp updates, risks, and decisions.
Why Join Us
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You'll play a pivotal role in bringing transformative AI technology to global dermatology markets--helping physicians deliver faster, more accurate, and accessible care.
If you thrive at the intersection of clinical research, regulatory strategy, and AI-enabled software, we'd love to hear from you.