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).

Responsibilities 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

Your Profile 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 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