Clinical Specialist

Kiwa Türkiye

Fatih

On-site

TRY 80,000 - 100,000

Full time

14 days+

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Benefits offered by this job

Kariyer gelişim programları

Global fırsatlar

Job summary

Bir Test ve Sertifikasyon Şirketi İstanbul'da Klinik Uzman arıyor. Bu pozisyon, klinik çalışmaların uyumunu kontrol etmek ve hukuki mevzuat bilgilerini takip etmeyi içermektedir. Tıp veya Diş Hekimliği mezunu ve en az 4 yıl deneyim beklenmektedir. Çalışanlar için sürekli gelişme fırsatları sunulmaktadır.

Qualifications

En az 4 yıl klinik uygulama deneyimi.
Tıbbi cihaz mevzuatı hakkında bilgi.
Kiwatr prosedürlerine hakimiyet.

Responsibilities

Klinik çalışmaların uyumunu kontrol etmek.
Hukuki mevzuat bilgilerini takip etmek.
Yeni başvuruları değerlendirmek.

Skills

Tıbbi cihaz bilgisi

Hukuki mevzuat bilgisi

Raporlama yeteneği

İletişim yeteneği

Education

Tıp veya Diş Hekimliği Fakültesi

Job description

Join to apply for the Clinical Specialist role at Kiwa Türkiye.

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 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 medical devices or similar products, and knowledge of the pathology of the condition treated and alternative treatments. The person must be currently employed in the field.
Knowledge of 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 MDR. This can be demonstrated through relevant work experience or training of at least 16 hours.
Adequate knowledge and experience pertaining to harmonised standards, Common Specifications (CS) and relevant guidelines (e.g. ISO 14155, Meddev 2.7.X, MDCG, etc.) that regulate the medical devices sector, demonstrable through work experience and training of at least 16 hours.
Knowledge of Kiwa TR procedures related to clinical data evaluation, demonstrated by specific training conducted by Kiwa TR.
Ability to draft records and reports, with correct performance of the relevant clinical evaluation activities, demonstrable through work experience with a notified body.

Beklentileriniz

You can constantly improve your personal, professional and technical competencies by participating in our academy programs that support your growth and career.

Opportunities for global opportunities and rotation among more than 10,000 engaged employees, working from over 40 countries can always knock on your door. We always applaud successes with different reward methods.

Seniority level