Quality & Regulatory Intelligence Specialist

Company Description
QMSROOT | RootAí is building a Quality Intelligence layer for regulated and quality-critical organisations.
Rather than replacing existing quality systems, QMSROOT is designed to work with governed quality and regulatory evidence to help teams understand what requires attention, why it matters, and what evidence supports the decision.
RootAí supports Quality and Regulatory professionals across workflows including CAPA, complaints and post-market surveillance, audits, nonconformances, controlled documentation, gap assessment and regulatory change.
Its role is advisory by design. RootAí helps analyse evidence, identify gaps and relationships, challenge unsupported conclusions, distinguish established facts from unresolved questions, and make the basis of its assessments visible.
RootAí advises. Quality decides. Evidence shows why.
Role Description
We are looking for a Quality & Regulatory Intelligence Specialist to support the development and application of QMSROOT | RootAí.
This is a part-time, remote role for someone who understands how Quality and Regulatory decisions are actually made — not only how procedures describe them.
The specialist will work across quality records, regulatory requirements and product workflows to help evaluate whether RootAí assessments are evidence-grounded, appropriately scoped and useful to Quality professionals.
Typical work may include reviewing CAPAs, complaints, audit findings, nonconformances, risk documentation and regulatory requirements; identifying recurring themes, evidence gaps and relationships; researching regulatory and quality requirements; challenging unsupported assumptions; supporting requirement mapping and impact assessments; and reviewing documentation or assessments generated through QMSROOT applications such as RootAí, DocAí and GapIdentAí.
The role will also contribute to improving internal Quality Intelligence frameworks, regulatory mappings, test scenarios and knowledge structures used to evaluate QMSROOT across different regulated environments.
Responsibilities
Review Quality and Regulatory evidence and assess whether conclusions are adequately supported.
Analyse CAPAs, complaints, audit findings, nonconformances, risk records and related Quality documentation.
Identify recurring issues, evidence gaps, inconsistencies and potential relationships requiring further investigation.
Conduct regulatory and Quality research using authoritative sources.
Support regulatory requirement mapping and change-impact assessments.
Review RootAí outputs for factual grounding, regulatory relevance, limitations and unsupported assumptions.
Review draft procedures and controlled-document content produced with DocAí.
Help develop realistic test cases for Quality Intelligence workflows.
Prepare concise, evidence-based summaries and recommendations for internal and external stakeholders.
Contribute to the continuous improvement of QMSROOT's Quality and Regulatory knowledge structures.
Qualifications
Strong analytical skills and the ability to interpret complex Quality and Regulatory information.
Practical experience in Quality Assurance, Quality Control, Regulatory Affairs or Quality Systems within a regulated or quality-critical environment.
Working knowledge of CAPA, nonconformance, complaints, risk management, audit findings and effectiveness checks.
Experience with Quality auditing, including audit preparation, evidence review, findings and follow-up activities.
Ability to challenge conclusions constructively and distinguish documented evidence from assumptions or interpretation.
Strong written and verbal communication skills.
Knowledge of regulatory frameworks relevant to industries such as medical devices, pharmaceuticals, diagnostics or other regulated sectors is highly beneficial.
Bachelor's degree in science, engineering, regulatory affairs, Quality or a related discipline, or equivalent practical experience.
Comfortable working remotely and with technology-driven Quality workflows.
Experience with eQMS platforms, regulatory databases, data-analysis tools or AI-enabled systems is an advantage.
Detail-oriented, intellectually curious and comfortable saying “the evidence does not support that conclusion yet.”

Work arrangement
Yes