Location

Turkey, Ankara

Job Type

80-100%

QA/RA

QM/RA

Key Tasks

  • 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.

Your Profile

  • 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

Our offer

  • Meaningful work on products that are life saving or support the therapy of patients in an effective manner
  • Flat hierarchy, truly interdisciplinary working community
  • Opportunity to contribute ideas, speak up and take decisions

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