Regulatory Affairs and Quality Assurance (RA/QA) Specialist

About The Job:We are looking for a highly motivated and detail-oriented Regulatory Affairs and Quality Assurance (RA/QA) Specialist to join our team at our facility located in Kahramankazan, Ankara. The ideal candidate will be responsible for ensuring compliance with ISO 13485:2016 and EU MDR 2017/745 standards, managing local and international product registration processes, and supporting the development and maintenance of the company’s quality management system. This is a great opportunity to work in a dynamic and innovative environment within the medical device sector.Qualifications:• Bachelor’s degree in Chemistry, Biology, Chemical Engineering, Biomedical Engineering, or Bioengineering• Experience in quality assurance within ISO 13485:2016 certified organizations• Ability to research and interpret regulations, standards, and international guidelines; familiarity with EU MDR 2017/745 is preferred• Knowledge of QMS processes such as Technical File preparation, CAPA, Complaint Management, Document Control, and Risk Management (ISO 14971:2019)• Strong communication, analytical thinking, planning, and organizational skills; team-oriented• Proactive, inquisitive, confident, and up-to-date with industry trends and developmentsJob Description• Prepare, revise, and update documentation related to ISO 13485:2016 and EU MDR 2017/745• Ensure the effective implementation and maintenance of the quality management system• Review and approve routine laboratory test results for product release• Manage the customer complaint handling process• Lead Corrective and Preventive Actions (CAPA) and risk management activities• Plan, organize, and conduct internal and external audits in compliance with ISO 13485:2016• Conduct literature reviews to support regulatory and quality activitiesOther informationWhat we offerRemote or flexible work opportunitiesExperience working in an international companyOpportunity to work with talented peopleIf you are interested in this opportunity and meet the above qualifications, please send your CV to ik@burgeon.me. We look forward to hearing from you.