Quality Assurance & Regulatory Affairs Engineer

High Tech Campus Eindhoven; Eindhoven; Hybrid; EUR 65,000 - 90,000; Full time

Benefits offered by this job

High Tech Campus Eindhoven

Excellent facilities

SARs equity

Job summary

Usono, a MedTech company revolutionizing MSK ultrasound, seeks a proactive Quality Assurance & Regulatory Affairs Engineer to ensure quality, safety and regulatory compliance across our medical device portfolio. You will support technical documentation, lifecycle activities and interact with R&D and production on site.

You’ll maintain EU MDR (2017/745) aligned documentation, assist regulatory submissions, control documents and aid audits and inspections, contributing to global market expansion

Qualifications

• Bachelor’s or Master’s degree in a relevant field (Biomedical Engineering, Life Sciences, Regulatory Affairs)
• 1–5 years of experience in Regulatory Affairs, Quality Assurance or Technical Documentation for medical devices
• Knowledge of EU MDR (2017/745), ISO 13485 and ISO 14971

Responsibilities

• Establish and maintain technical documentation and regulatory submissions for the medical device portfolio
• Manage document control and lifecycle activities within the Quality Management System
• Support internal and external audits, inspections and regulatory inquiries
• Assist in risk management documentation, labeling and IFU preparation
• Coordinate with R&D, Operations and external regulatory partners on lifecycle compliance
• Support medical device assembly, testing and production activities on site

Skills

Regulatory Affairs

Quality Assurance

Technical Documentation

MDSW Experience

Multidisciplinary Collaboration

Education

Bachelor’s or Master’s in Biomedical Engineering / Regulatory Affairs

Tools

EU MDR 2017/745

ISO 13485

ISO 14971

Job description

Quality Assurance & Regulatory Affairs Engineer

Jobs

Help ensure the quality, safety, and compliance of innovative medical technologies. As a QARA Engineer at Usono, you maintain quality management processes, support regulatory activities, and help meet international medical device standards. An excellent opportunity for a detail-oriented professional passionate about healthcare innovation and continuous improvement.

Usono is a MedTech company that revolutionizes musculoskeletal (MSK) ultrasound through dynamic imaging solutions. Our main product, ProbeFix Dynamic, is used by doctors of elite sports organizations such as Lugano FC, Torino FC and research institutions such as Mayo Clinic and MIT. Thanks to our hardware, they unlock new insights in the body in movement, for prevention, diagnosis and rehabilitation.

We are seeking a proactive Quality Assurance & Regulatory Affairs Engineer to support our medical device portfolio throughout its lifecycle. In this role, you will support technical documentation, quality and regulatory activities, and ensure compliance with applicable medical device regulations. You will work closely with R&D and production teams, while also providing hands‑on support for medical device assembly and production on site.

The Job

As our Q&R Engineer, you will support establishing technical documentation, regulatory submissions, document control, and lifecycle support activities for our medical device portfolio. You will work closely with R&D and Operations to ensure our products remain compliant throughout their lifecycle while supporting international market expansion. You’ll shape the future of dynamic ultrasound by:

• Maintaining and updating technical documentation in compliance with EU MDR (2017/745)
• Supporting regulatory submissions and registrations
• Managing documentation updates for new product variants and design changes
• Maintaining document control processes within our Quality Management System
• Supporting the preparation of risk management documentation, labeling, device descriptions, and Instructions for Use (IFU)
• Ensuring documentation remains complete, consistent, and audit‑ready
• Supporting internal and external audits and regulatory inspections
• Contributing to the continuous improvement of quality procedures, templates, and documentation processes
• Working closely with engineering, clinical, production and external regulatory partners
• Supporting medical device assembly, testing, and production activities on site
• Maintaining production‑related documentation and traceability records in line with quality and regulatory requirements

Who You Are

We’re looking for a proactive and detail‑oriented professional who enjoys creating structure in a fast‑moving MedTech environment.

• Bachelor’s or Master’s degree in (Biomedical) Engineering, Life Sciences, Regulatory Affairs, or a related field
• 1-5 years of experience in Regulatory Affairs, Quality Assurance, or Technical Documentation for medical devices
• Knowledge of EU MDR (2017/745), ISO 13485 and ISO 14971
• Experience with technical documentation and document control
• Strong written communication skills and attention to detail
• Comfortable working with multidisciplinary teams
• Experience with Medical Device Software (MDSW)
• Experience supporting regulatory submissions, audits, or notified body interactions

What We Offer

• Working on the High Tech Campus Eindhoven with amazing facilities
• The opportunity to build a unique Medical Device proposition
• A chance to contribute to medical innovation used in elite sports, rehabilitation and healthcare worldwide.
• Potential to participate in equity through SARs (details to be communicated in later interview stage).