Regulatory Affairs Specialist/Raporlama Uzmanı

Set Medikal San. Tic.A.Ş.

Qualifications: 

• Bachelor degree in Engineering and Technical or Health/Life Sciences departments of universities. 
• Preferably 2 to 3 years experience in Regulatory  Affairs  Management in a multinational environment (medical  industry would be an asset). 
• Working knowledge of regulatory registrations in Turkey or other countries. 
• Working knowledge of ISO 13485, MDD (93/42/EEC), FDA requirements and the other global regulations. 
• Knowledge in MS Office software (Word, Excel, Powerpoint, Outlook), and SAP is required. 
• Excellent command of written & spoken English is mandatory. 
• Team player with excellent communication and presentation skills; able to develop collaborative relationships with various stakeholders both internal and external to achieve objectives. 
• Analytical thinking, result and solution oriented, innovative, proactive, flexible and strong ability on problem solving  and reporting. Must be able to identify creative options for resolving issues that respond to multiple stakeholder interests and needs, 
• Strong planning, follow up, reporting, coordination and organization skills to achieve accurate and  timely results. 
• No military obligation for male candidates. 
• Be confident, positive, self-motivated & able to work independently 
• Be a good teamplayer 
• Good communication skills 
• Teamwork oriented, ability to establish and maintain effective working relationships\ willingness to learn 

•  Implement  and support registration and re-registration tasks with the authorities. 
• Support the establishment and development of the RA system. 
• Responsible for coordination and implementation of RA activities in line with international regulations, Set Medikal policies and procedures. 
  
• Ensure the completion of regulatory  certification/registration/notification/listing activities in  a correct and  timely manner. 
• Evaluate the effects of change control activities from regulatory perspective and implement required regulatory  steps on a timely manner. 
• Follow the currency and delivery of quality documents and records to the third parties during registration activities. 
• Follow-up of developments and changes in the local & international regulatory policy rules, legislations and guidelines with impact to Set Medikal activities. Analyze available regulatory and compliance information. 
• Update of domestic (Product Tracking System) and international product registrations, to keep track of the up-to-dateness of the registered products, to fulfill the neccessary updates on time. 
• To follow the actuality of the representatives and certificates registered in the ÜTS system and, in case of revision, to contact the relevant manufacturers and upload the new certificates to the system in a timely manner. 
• Communicating with the Ministry and other official institutions, responding to letters from these institutions including subsequent recording and archiving activities 
• To perform and follow-up Eudamed record entries