Regulatory Affairs & QA Associate (Medical Devices)

About the role

You will work at the intersection of regulatory affairs and quality assurance for medical devices focused on wound healing. The position involves preparing documentation for product submissions across multiple regions and maintaining the electronic Quality Management System.

Key responsibilities

• Prepare technical and submission documents for Europe, US, Middle East and APAC markets.
• Support notified body and authority audits.
• Upload and maintain external documents, supplier approvals, change‑management and CAPA cases in the QMS.
• Update SOPs, work instructions and records as part of continuous improvement.

Required profile

• Bachelor's or master's degree in manufacturing engineering, biomedical engineering or natural sciences.
• At least 2 years of experience in Medical Device Regulatory Affairs and Quality Assurance.
• Additional training or certificates in Medical Device RA/QA is a plus.
• Strong ability to prioritize tasks and meet deadlines.
• Excellent communication, presentation and technical writing skills.

Required skills

• Proficiency with ISO 13485.
• Knowledge of ISO 14971.
• Understanding of 21 CFR Part 820.
• Familiarity with EU MDR requirements.