QA/RA Specialist — Path to Leadership in Med Devices

Nuwhï bv; Antwerpen; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Nuwhï bv in the Antwerp region is seeking a QA/RA Specialist to strengthen the quality and regulatory framework for medical devices. You will work with the existing QA team to ensure products, processes and documentation meet ISO 13485 standards and EU MDR requirements.

This role offers growth toward broader leadership responsibilities, with exposure to audits, regulatory filings, and collaboration with manufacturing partners across Europe.

Qualifikationen

• 4–8 years in Quality Assurance and/or Regulatory Affairs in the medical device industry.
• Practical knowledge of ISO 13485 and EU MDR.
• Experience with Quality Management Systems, audits and regulatory documentation.
• Hands-on, structured and solution-oriented approach.
• Ability to work independently and take ownership.
• Strong communication and collaboration skills.
• Fluency in English; Dutch is an advantage.

Aufgaben

• Maintain and further develop the Quality Management System (ISO 13485).
• Support ongoing compliance with EU MDR.
• Manage and update technical and regulatory documentation.
• Prepare for and participate in internal and external audits, with corrective actions.
• Coordinate with external manufacturing and sterilisation partners on QA.
• Contribute to quality control, release processes and continuous improvement.
• Collaborate with stakeholders to embed quality and regulatory requirements in daily operations.
• Support new product developments from a QA/RA perspective.
• Take increasing ownership of QA/RA projects as experience grows.

Kenntnisse

Quality Assurance

Regulatory Affairs

ISO 13485

EU MDR

Quality Management System

Audits

Regulatory documentation

PRRC

Jobbeschreibung

Nuwhï bv in the Antwerp region is seeking a QA/RA Specialist to strengthen the quality and regulatory framework for medical devices. You will work with the existing QA team to ensure products, processes and documentation meet ISO 13485 standards and EU MDR requirements.

This role offers growth toward broader leadership responsibilities, with exposure to audits, regulatory filings, and collaboration with manufacturing partners across Europe.