Clinical Specialist

Kiwa Türkiye; Fatih; On-site; TRY 140,000 - 220,000; Full time

Job summary

Kiwa Türkiye Medical Division’a Tuzla, İstanbul adresinde yer alan klinik uzmanı pozisyonu için başvuru yapılıyor. klinik çalışmaların uygunluğunu denetlemek ve teknik dosyalar için raporlar üretmek göreviyle görevlendirileceksiniz.

İlgili mevzuata hakim, klinik veri değerlendirme konusunda deneyimli ve Kiwa TR prosedürlerine aşina bir profesyonel aranmaktadır. Uluslararası mevzuat ve kalite standartlarıyla çalışmayı seven adaylar tercih edilir.

Qualifications

• Tıp veya diş hekimliği fakültesi mezunu olmak.
• Klinik uygulama tecrübesi en az 4 yıl.
• EU Regulation 2017/745 MDR ve Annex I performans ve güvenlik gereksinimlerini bilenler.
• Klinik veri değerlendirme, uygun eğitim/deneyim ile gösterilebilmeli.
• Kiwa TR prosedürlerine ilişkin klinik veri değerlendirme bilgisi edinmiş olmak.

Responsibilities

• Klinik çalışmaların ve raporların teknik dosyalarındaki uygunluklarını kontrol etmek ve Kiwa tarafından iletilen bilgileri raporlamak.
• Klinik değerlendirmenin mevcut mevzuatı izlemek ve EU/regülasyonlarla ilgili belgeleri paylaşmak.
• EU, FDA ve Sağlık Bakanlığı tarafından yayımlanan olumsuz olaylar ve geri çağırma bildirimlerini izlemek ve Kiwa ile paylaşmak.
• Kiwa tarafından sunulan başvuruları değerlendirmek ve görüş raporlarını bildirmek.

Skills

Medikal uzmanlık

Regülasyon bilgisi MDR

Klinik değerlendirme tecrübesi

Education

Tıp Fakültesi Mezunu

Dişhekimliği Fakültesi Mezunu

Job description

İş Özeti

Kiwa is a world top 20 leader in Testing, Inspection and Certification (TIC). With our certification, inspection, testing, training and consultancy services, we create trust in our customers' products, services, processes, (management) systems and employees. We do so in a wide variety of markets segments, ranging from construction and energy supply to drinking water, healthcare, food, feed & farming. Kiwa employs over 10,000 people in over 40 countries, in Europe, Asia, the Americas and Oceania. Since 2021 we are a member of SHV Family of Companies. We are looking for a ‘CLINICAL SPECIALIST’ to join our company for our Medical Division, located in Tuzla, İstanbul.

İş Tanımı

• Checking and reporting compliance of clinical studies and reports in the technical files of the customer communicated to them by Kiwa
• Current training on clinical evaluation. Tracking the information and documents sent by Kiwa
• Monitoring and sharing of legal legislation and guide documents related to clinical evaluation published by the EU and Ministry of health
• Monitoring and sharing of negative events and recall notifications published by the EU, FDA and Ministry of health and sharing with Kiwa
• Evaluation of new applications submitted by Kiwa and reporting of opinions

İş Gereklilikleri

• Graduated from Faculty of Medicine or Faculty of Dentistry
• Work experience in clinical practice with a duration of at least 4 years, related to the use of the medical device or similar products, to the knowledge of the pathology of the condition to be treated and to the relative alternative treatments in relation to the devices and to other products. The person must be currently employed in the field.
• Knowledge of the current legislation (EU Regulation 2017/745, provisions established by control bodies, etc.) governing medical devices, including the performance and safety requirements set out in Annex I of the MDRMDR which can be demonstrated through relevant work experience or training with a duration of at least 16 hours.
• Adequate knowledge and experience pertaining to the harmonised standards, of Common Specifications (CS) and relevant guidelines (e.g. ISO 14155, MeddevMeddev 2.7.X, MDCGMDCG, etc.), that regulate the medical devices sector, which can be demonstrated through work experience and training with a duration of at least 16 hours.
• Knowledge of the relevant KiwaKiwa TR procedures related to clinical data evaluation, demonstrated by specific training conducted by KiwaKiwa TR.
• Ability to draft records and reports, with the correct performance of the relevant clinical evaluation activities, which can be demonstrated through work experience with a notified body.

Beklentileriniz

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