Regulatory & Compliance Lead
Job Type: Full Time
About MetaOptima:
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 Regulatory and Compliance Lead with extensive experience in device approvals in US, Europe, Canada, Australia and the United Kingdom. The incumbent must be well-versed in regulatory requirements for hardware and software medical devices in those jurisdictions and applicable standards such as ISO 13485: 2016, ISO 14971: 2019 and IEC 62304: 2006, IEC 62366-1:2015 and ISO 14155:2020. Priority will be given to individuals with proven ability to successfully complete EU MDR and MDSAP auditing processes.
Qualifications & Skills:
5+ years in regulatory program management for SaMD, AIaMD, or medical imaging devices.
Track record with SaMD or AI-enabled software in healthcare, including leading at least one successful FDA submission (e.g., 510(k) or De Novo), CE marking of a device above Class IIa or Health Canada device licensing..
Practical understanding of ISO 13485, ISO 14971, IEC 62304, 21 CFR Part 11, EU MDR, CMDR, Australian Therapeutic Goods (Medical Devices) Regulations, GCP, and data-privacy basics (HIPAA; GDPR awareness).
Experience maintaining ISO 13485, ISO 14971 and IEC 62304 -compliant quality management system
Deep knowledge of design controls, risk management, usability engineering, verification and validation.
Experience interacting with notified bodies and regulatory authorities such as the US FDA, Health Canada and TGA.
ISO 13485:2016 Medical Device Lead Auditor certification
RAC certification will be an asset
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.
Knowledge of statistical analysis for power calculations
Familiarity with human-factors/usability files and labeling (IFU, indications/contraindications).
Responsibilities:
Successful completion of EU MDR and MDSAP audits
Successful completion of device approvals in the EU, Canada, Australia, US and UK
Maintenance of a ISO 13485, ISO 14971 and IEC 62304 -compliant quality management system
Hosting external audits
Primary point of contact with regulatory authorities and notified bodies.
Privacy compliance (HIPAA, GDPR, PIPEDA etc.)
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.
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
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.
