Responsible for the management, improvement, and documentation of the QMS according to relevant regulatory standards and requirements.

Monitor product performance and drive quality improvements.

Support teams to resolve non-conformities, corrective and preventive actions and other quality relevant topics.

Conduct internal and supplier audits.

Responsible for registrations of new or improved products with focus on phototherapy devices as well as keeping up-to-date existing registrations.

Compilation of submission dossiers in close collaboration with internal and external stakeholders.

Responsible to report incidents to the competent authority. Support implementing necessary measures internally, and in the market (FSCAs).

Support of preparation, implementation and follow-up of audits by competent authorities.

Follow up on national regulatory requirements and standards for continuous monitoring.

Degree in life sciences

Experience in a Quality Management and/or Regulatory Affairs position for medical devices

In depth knowledge of the regulatory framework of medical devices

Strong analytical thinking

Fluent in Turkish and English, German is a plus