MedTech QA & Regulatory Affairs Engineer (Equity Potential)

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

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