Quality Assurance Specialist

Quality Assurance Specialist

We are currently supporting a medical device company that is strengthening its QMS to ensure full compliance with EU regulatory requirements and continuous process improvement. To support this initiative, we are seeking a Quality Assurance & Regulatory Compliance Consultant to contribute to the implementation and maintenance of an ISO 13485-based QMS while supporting regulatory compliance activities under EU MDR (2017/745).

• Support the implementation, maintenance, and continuous improvement of the QMS
• Develop and maintain quality documentation (SOPs, forms, records)
• Support supplier qualification activities and participate in internal and external audits
• Assist in CAPA management, complaint handling, and non-conformity processes
• Ensure compliance with ISO 13485 and EU MDR (2017/745)
• Support technical documentation maintenance and regulatory compliance activities
• Contribute to PMS and vigilance processes
• Verify labelling, packaging, and regulatory documentation compliance
• Support regulatory registrations and database submissions (e.g. UDI / EUDAMED where applicable)
• Collaborate cross-functionally to ensure adherence to quality and compliance standards

• Degree in Biomedical Engineering, Biotechnology, Life Sciences, or related field
• Minimum 5 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry
• Strong working knowledge of ISO 13485
• Good understanding of EU MDR (2017/745)
• Experience with Risk Management (ISO 14971)
• Experience supporting audits (internal and external)
• Fluency in English, written and spoken