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