Quality Assurance & Regulatory Affairs Engineer

Usono; Eindhoven; Hybrid; EUR 54,000 - 78,000; Full time

Job summary

Usono in Eindhoven is seeking a proactive Quality Assurance & Regulatory Affairs Engineer to support EU MDR compliance, technical documentation, and lifecycle management of our medical device portfolio. You will collaborate with R&D, Operations, clinical, and external regulatory partners on site to keep products compliant and ready for international markets.

You will maintain and update technical documentation, support regulatory submissions, manage document control, and contribute to risk

Qualifications

• 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.

Responsibilities

• Maintain and update technical documentation in compliance with EU MDR (2017/745).
• Support regulatory submissions and registrations.
• Manage documentation updates for new product variants and design changes.
• Maintain document control processes within our Quality Management System.
• Support risk management documentation, labeling, device descriptions, and IFU creation.
• Ensure documentation remains complete, consistent, and audit-ready.
• Assist with audits and regulatory inspections and contribute to process improvements.
• Collaborate with engineering, clinical, production and external regulatory partners.
• Support medical device assembly, testing, and production activities on site.
• Maintain production-related documentation and traceability records.

Skills

Regulatory affairs knowledge

Quality Assurance experience

Documentation skills

Cross-functional collaboration

Attention to detail

Education

Bachelor's or Master's degree in Biomedical Engineering / Life Sciences / Regulatory Affairs

Job description

About Usono

Usono is a MedTechcompany that revolutionizesmusculoskeletal (MSK) ultrasound through dynamic imaging solutions. Our main product, ProbeFix Dynamic, is used by doctors of elite sports organizations such asLugano FC,TorinoFCand research institutions such asMayo Clinic andMIT. Thanks to our hardware, they unlock new insights in the body in movement, for prevention,diagnosisand 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 inspectionsContributing 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,rehabilitationand healthcare worldwide.
• Potential toparticipatein equity through SARs (details to be communicated in later interview stage).