Supplier management
Developed eQMS supplier-management workflows, controlled procedures and templates.
Quality Assurance & Regulatory Affairs Specialist
Chiara
Spasiano.
Biomedical engineer · MedTech
Quality with clarity.
Biomedical engineer and QA/RA professional based in Zurich, Switzerland. My experience connects medical-device quality systems, regulatory documentation and product development — from development to market readiness.
Based in Zurich, Switzerland Open to connect
Quality. Regulatory. Human.ISO 13485 / ISO 14971
01 / SELECTED CONTRIBUTIONS
Evidence in practice.
QA / RA / MedTechUS quality systems
Led a US quality-system gap assessment and tracked follow-up actions and controlled updates.
Regulatory framework
Built an EU/US regulatory-requirements framework and supported FDA submission activities.
02 / PROFILE
About me
Where requirements become workable systems.
CurrentlyQuality Assurance SpecialistMYNERVA AG
Biomedical engineer with a Master's degree and experience across QA/RA and product development in regulated environments.
My work supports the development and market readiness of disruptive medical devices and combination products through quality, regulatory and product-development activities across the lifecycle.
03 / FOCUS
Core expertise.
Translating regulatory requirements into structured documentation, clear decisions and quality processes that work in practice.
01
Quality Systems
Maintaining and improving an ISO 13485 quality management system in Greenlight Guru, with hands-on responsibility across core quality processes.
02
Regulatory Affairs
Monitoring EU and US requirements, performing gap analyses and refining technical documentation for regulatory interactions and submissions.
03
Product & Risk
Connecting regulatory thinking with design, development, testing and risk management across the medical-device product lifecycle.
04 / EXPERIENCE
Selected journey
From product to
compliance.
Experience across medical devices, wearables, biomaterials, sportswear testing and academic research.
Aug 2026 — Present
MYNERVA AG
Zurich, CHQuality Assurance Specialist
Wearable technologies for peripheral neuropathy
2025 — 2026
Hylomorph AG
Zurich, CHQuality Assurance & Regulatory Affairs Associate
Medical device / combination product · Infection prevention
- Maintained and improved the ISO 13485 quality management system in Greenlight Guru.
- Monitored EU/US requirements, performed gap analyses and refined technical documentation.
2024
Hylomorph AG
Zurich, CHProduct Development Engineer
Biomaterials, API-loaded films, experimental protocols and laboratory operations
2023 — 2024
On
Zurich, CHProduct Testing Specialist R&D
Testing procedures, validation and analysis across 100+ product samples
2023
Vorn AG
Wollerau, CHProduct Development Engineer
Wearable ECG monitoring technology for medical and sports applications
2022 — 2023
ETH Zurich · Balgrist Campus
Zurich, CHMaster Thesis Student & Research Assistant
Textile wearable sensing, motion analysis and energy harvesting
05 / BEYOND THE CV
How I work
Calm in complexity.
Kind by default.
Warm and collaborative, calm and open-minded, curious and growth-oriented — with the resilience to keep moving through ambiguity.
“If you are kind, then you belong.”
Warm & collaborative
Trust, openness and mutual support turn quality into a shared responsibility.
Calm & open-minded
Listen first, communicate respectfully and make space for different perspectives.
Curious & growth-oriented
Learn continuously, seek new perspectives and ask better questions.
Resilient in challenges
Combine discipline and persistence with balance and self-kindness.
06 / EDUCATION & SKILLS
Foundation
Engineering meets human impact.
MSc Biomedical Engineering
ETH Zurich & Politecnico di Milano
Biomechanics & Biomaterials Engineering · Thesis grade 5.5/6BSc Biomedical Engineering
University of Padova
Research internship at Rizzoli Orthopaedic HospitalTools
Greenlight Guru · SolidWorks · OriginLab · LabVIEW · Jira · Confluence · Smartsheet
Code
Python · MATLAB · LaTeX
Languages
Italian · English C1 · Spanish B2 · German B1
07 / PUBLICATIONS
Scientific work.
Research across biomechanics, wearable sensors, triboelectric textiles and implantable biomaterials.
01Accuracy and correlation between skin-marker based and radiographic measurements of medial longitudinal arch deformationView publication ↗02Integrated spacer-free triboelectric textiles for subtle movement tracking and natural body motion energy harvestingView publication ↗03Wireless Motion Variability Analysis with Integrated Triboelectric Textiles via Displacement CurrentView publication ↗04Distant transport of antimicrobial protection by implantable polymeric meshesUnder review
Contact
Let's make quality
work.
Recruiting for a Quality Assurance or Regulatory Affairs role in MedTech? Get in touch to discuss my experience in medical devices, quality systems and product development.