MedTech QA & 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

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