Remote EU Regulatory & Quality Specialist

Surgerii Robotics; Netherlands; On-site; EUR 60,000 - 90,000; Full time

Job summary

Surgerii Robotics is seeking a QA/RA professional to own the EU QMS daily operations, including complaint handling, CAPA, RMA and document control. You will coordinate with global teams to ensure compliance with EU MDR and ISO 13485 and drive continuous improvement.

The role requires 2+ years in medical device QA/RA, strong English, and the right to work in the Netherlands. Remote work with occasional travel to EU repair facilities and Amsterdam office is expected.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Biomedical/Mechanical Engineering, or a related technical/regulatory field.
• Minimum 2+ years of QA/RA experience in the medical device industry (EU MDR environment preferred).
• Fluency in English; Dutch/German a plus.

Responsibilities

• Receive, log, triage and assess product complaints from EU hospitals.
• Maintain the complaint register and ensure traceability across complaint, RMA and field service records.
• Initiate and track CAPA processes; coordinate investigations (Beijing) and verify CAPA effectiveness.
• Manage RMA/repair master records in the Netherlands as single source of truth.
• Generate RMA numbers and process returns from hospitals.
• Manage the QMS document stack per ISO 13485 and EU MDR, including training and retention.

Skills

QA/RA experience

EU MDR knowledge

Complaint handling

Document control

English proficiency

Dutch/German a plus

Education

Life Sciences / Biomedical Engineering

Job description

Surgerii Robotics is seeking a QA/RA professional to own the EU QMS daily operations, including complaint handling, CAPA, RMA and document control. You will coordinate with global teams to ensure compliance with EU MDR and ISO 13485 and drive continuous improvement.

The role requires 2+ years in medical device QA/RA, strong English, and the right to work in the Netherlands. Remote work with occasional travel to EU repair facilities and Amsterdam office is expected.