QM/RA Manager – Quality Management & Regulatory Affairs (Medical Devices)

Projects and Responsibilities

• Own the QMS: Run and continuously improve our ISO 13485:2016 quality management system in Qualio (our electronic QMS and system of record) — document and change control, training, CAPA and nonconformance handling, internal audits, supplier control and management review — and take it from operating to Notified Body audit-ready. Keep the QMS aligned with FDA QMSR (21 CFR Part 820).
• Own the Technical Documentation: Build and maintain the EU MDR (2017/745) technical documentation (Annex II/III) for our products: GSPR checklist, risk management file (ISO 14971), usability engineering file (IEC 62366-1), software lifecycle documentation (IEC 62304 — Class A firmware), clinical evaluation (Article 61 / MDCG 2020-13), cybersecurity documentation (MDCG 2019-16), labeling and IFU, and the PMS plan and PSUR.
• Regulatory Strategy and Submissions: Drive the conformity assessment route for each product and be our day-to-day contact with the Notified Body — pre-submission meetings, submission packages, responses to questions and observations, audit preparation. Complete EUDAMED actor and device registration and UDI assignment. Support our FDA pathway together with our external regulatory advisors.
• Design Controls and Design Transfer: Embed design controls (ISO 13485 §7.3 / 21 CFR 820.30) in the engineering workflow — design reviews, design inputs and outputs, verification and validation planning, traceability, design change assessment — and support design transfer to production together with our Manufacturing Lead: Device Master Record, process validation (IQ/OQ/PQ) and first article inspection.
• Supplier and Partner Quality: Own quality agreements, supplier criticality classification, supplier audits and change-notification requirements for our contract manufacturers and component suppliers.
• Post-Market and Launch Readiness: Set up complaint handling, vigilance and incident reporting, post-market surveillance and PMCF processes before launch, so we ship a compliant, audit-ready product from day one.
• Be the Go-To Person: Promote regulatory and quality awareness across engineering, manufacturing and commercial; be the contact point for all questions on technical documentation and product approval; report to the CEO on the effectiveness of the QMS and any need for improvement.

• Experience has higher leverage than degrees — we'll review all applications.
• Hands-On QM/RA Depth: 3+ years of hands-on quality and regulatory work on medical devices, where you personally authored or owned technical documentation — not only coordinated it. You can show us a technical file, a risk file or a submission you built, and an audit you hosted.
• EU MDR and Standards: Very good working knowledge of EU MDR 2017/745 and MDCG guidance, and of ISO 13485, ISO 14971, IEC 62304 and IEC 62366-1. You know what a Notified Body expects and how to answer a deficiency letter.
• Hardware and Software: Experience with physical, electromechanical or connected devices — design controls, labeling, UDI, process validation — and with medical device software (MDSW/SaMD): software classification, lifecycle documentation, cybersecurity.
• QMS Operation: Hands-on experience running a QMS under ISO 13485 — internal audits, CAPA, document control — ideally in an electronic QMS (Qualio or similar) and with Confluence and Jira.
• Way of Working: Structured, conscientious and systematic, with excellent written and verbal English. Solution-oriented get-things-done attitude; comfortable making decisions with incomplete information at an early-stage company and able to bring others along. Willing to use AI tools daily for drafting, review and traceability work.
  
  
  
• Bonus Qualifications: Taking a device from pre-CE to CE marking and/or through FDA De Novo or 510(k). EUDAMED and GS1 UDI hands-on. Notified Body QMS audit (MDR Annex IX) or MDSAP experience. IEC 60601 / EMC test campaign coordination. Cybersecurity documentation (IEC 81001-5-1, SBOM). HIPAA / ISO 27001 posture for cloud health data. Process validation (IQ/OQ/PQ). Eligibility to act as Person Responsible for Regulatory Compliance (MDR Article 15). Icelandic language skills.

As part of our team, you'll enjoy a range of perks designed to support your professional growth and personal well-being. After all, we aim to save patients' lives!

• We offer lunch and you'll get access to the best available AI tools and technologies.
• We understand the importance of work-life balance and offer flexible working hours. We're a family-first workplace.
• We offer competitive salaries based on competences and we have a vesting plan for employees.