Technical Product & Regulatory Manager (Medical Software / MDR) (m/f/d)

ph3Overview /h3 pQUMEA builds radar-based, contactless patient monitoring. Our RADIQ sensor platform watches over patients without cameras and without anything worn on the body, giving care teams in hospitals and long‑term care reliable information on mobility, immobility and, increasingly, vital signs. We are a Swiss MedTech company with a growing presence across Switzerland, the Nordics and the wider EU, and a subsidiary in Stockholm. New flagship use cases (respiration and immobility monitoring) and AI features are expanding our regulatory surface significantly, and we have no in‑house regulatory expert embedded in product development. That is the gap you fill. /p h3Responsibilities /h3 ul liRequirements translation: translate MDR (EU 2017/745), IEC 62304 and ISO 14971 into clear product and engineering requirements. /li liRequirements engineering and traceability: own requirements engineering, traceability and risk‑related requirements across software, algorithms and devices. /li liVerification and validation: drive VV – planning, evidence collection and reporting. /li liTechnical documentation: write and maintain the technical documentation, including design history, risk files and VV records. /li liProcess embedding: embed regulatory compliance into the development process and improve the process where it blocks the team rather than helping it. /li liAudit readiness: support audit readiness for ongoing certifications and for new features (respiration, immobility monitoring, AI). /li liClinical evaluation support: support our clinical evaluation work for the software features (clinical evaluation planning and evidence) together with our research and clinical partners. /li /ul h3Qualifications /h3 h3Must‑haves /h3 ul liSolid regulatory experience for medical software, with practical command of MDR, IEC 62304 and ISO 14971. /li liHands‑on experience with requirements engineering, traceability and verification and validation in a regulated software environment. /li liStrong, clear technical writing: happy to produce design history, risk files and VV records yourself. /li liAbility to work shoulder to shoulder with software, algorithm and device engineers and to embed compliance into how they actually develop. /li liStructured, pragmatic and self‑driven. /li /ul h3Preferred skills /h3 ul liExperience with Software as a Medical Device and cloud‑hosted / SaaS‑delivered medical products. /li liExposure to Class I and to the move toward Class IIa software, and to taking new regulated software functions through development to market. /li liExperience supporting clinical evaluations and study evidence for software features. /li liFamiliarity with the Swiss and EU landscape (Swissmedic, EU markets). /li liComfort with modern, AI‑assisted documentation and tooling. /li /ul h3Benefits /h3 ul liA central, hands‑on role at the point where regulation meets real product development. /li liClose collaboration with our software, algorithm and device teams, the CTPO and the PRRC. /li liA meaningful product and a company that wants to do regulation the serious way. /li liA pragmatic, fast‑moving Swiss MedTech environment. /li /ul h3About us /h3 pQUMEA is a pioneer in digital patient mobility monitoring and is setting new standards in patient safety. Our radar‑based system captures movements in patient rooms completely contactlessly and anonymously, supporting healthcare professionals in real time whenever patients need assistance. The result: greater safety for patients, noticeable relief for nursing staff, and clear clinical added value. /p h3Application /h3 pTo apply, submit your CV and relevant supporting documents. /p /p #J-18808-Ljbffr