Specialist roles in regulated digital health
We are building the governance layer for digital health technologies in clinical trials — and we are always looking for specialists who want that work done properly.
We are always looking for
Life sciences and technology specialists who want regulated work done properly — not just documented.
Quality Assurance Specialist
Ensures compliance with global quality standards by developing, implementing, and maintaining Quality Management Systems (QMS). Conducts audits, identifies gaps, and drives continuous improvement initiatives.
Compliance Consultant
Offers tailored strategies for adhering to industry regulations and standards. Supports organisations in navigating audits, certifications, and regulatory approvals.
Process Improvement Specialist
Focuses on optimising internal workflows and QMS to enhance operational efficiency. Identifies bottlenecks and implements best practices to improve productivity and compliance.
Validation Engineer
Ensures that equipment, processes, and systems meet regulatory requirements through validation protocols. Conducts tests and provides reports to support compliance.
Regulatory Project Manager
Leads cross-functional teams to ensure timely and efficient execution of regulatory projects, including submissions, audits, and compliance initiatives. Manages timelines, budgets, and resources while ensuring alignment with global regulatory standards and organisational goals.
Part 11 Compliance Specialist
Ensures systems and processes comply with FDA 21 CFR Part 11 requirements for electronic records and signatures. Oversees validation activities, audits digital systems for compliance, and develops policies and procedures to maintain regulatory adherence.
DHT Regulatory Assessor
Runs the Regulatory Impact Assessment: one device, one protocol, seven perimeters. Records the decision and the reasoning behind it, writes the trigger list, and signs the register entry. The role that produces the artefact everything else hangs from.
Quality & Regulatory Assurance Lead
Builds and holds quality systems under ISO 13485:2016 and FDA QMSR, and runs the audits that find gaps before an inspector does. Qualified to hold the PRRC role under EU MDR and IVDR for clients who need a named, accountable person.
Regulatory Affairs Manager
Owns classification and submissions across jurisdictions — EU MDR and IVDR, FDA 510(k) and De Novo, UK, Japan, Canada. Writes justifications to survive challenge, maintains EUDAMED registrations, and tracks where the frameworks diverge at the edges.
Computer System Validation & CSA Lead
Plans and leads computer system validation for GxP systems and moves teams from document-heavy CSV to risk-based computer software assurance, scaling testing to the risk a function carries. Applies ALCOA+ where data is created — on the handset, the sensor, the analyser — not only in the validated database it eventually reaches. Designs audit trails someone actually reviews, remediates integrity failures, and looks first at the spreadsheets between systems.
Medical Device Software Engineer
Builds software as a medical device and software in a device under IEC 62304: safety classification, architecture, SOUP management, verification, and the software part of the technical file. Runs ISO 14971 risk management throughout, not as a document at the end.
Risk Management & Human Factors Specialist
Owns ISO 14971 hazard analysis, FMECA and FTA, and usability engineering under IEC 62366-1 for participant-facing devices. Assesses use error in an unsupervised home setting, where most software hazards are use hazards.
Clinical Operations Lead — DHT Deployment
Has run trials from the sponsor or CRO side and deployed wearables, sensors, eCOA and participant-owned devices into them. Designs logistics, training and remote-monitoring programmes so the device works at site, at home and at inspection.
Engagement Lead
Runs assessments and transformation phases to a written scope, a fixed fee and a stated date. Holds the gate — go/no-go with defined exit criteria and a named approver — and gives the client the readout personally. No delivery pyramid between you and the work.
Apply here
Submit your CV and a brief statement of interest. You can email applicant@qointa.com directly, or use the form below.