Clinical Evaluation Specialist İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
GENEL NİTELİKLER
Bıçakcılar is a global biomedical technology company headquartered in Istanbul, Turkey that designs, develops solutions and produces medical disposables, therapies and medical equipment to serve mostly the surgical space through R&D, Innovation, Laboratory Services and expert production with the continuous target for the safest, accessible medical devices built on saving human life.
Turkey's leading manufacturer of medical devices and disposable medical devices and brand of our company to serve in our factory in Esenyurt, we are looking for an "Clinical Evaluation Specialist" with following qualifications.
QUALİFİCATİONS
- A degree in life science, biomedical engineering, chemical engineering, bioengineering, or a relevant engineering degree is required.
- Proficiency in English writing and speaking is required.
- MS degree is preferred.
- 0-2 years of working experience in medical device and pharmaceutical companies is preferred.
- 0-2 years of scientific writing or technical file documentation experience is preferred.
- Knowledge and experience in Medical Device Regulation, scientific writing, statistics is preferred.
JOB DESCRİPTİON
- Analyze and synthesize a vast amount of pre-clinical data, risk management assessments, benchmark data, published literature, clinical investigation results, and post-market surveillance data to evaluate the device’s safety and performance according to Medical Device Regulation 2017/745.
- Analyze current state-of-the-art trends related to medical devices, clinical indications, and techniques.
- Interface with key functional areas (e.g., R&D, Quality, Manufacturing) to obtain necessary information and documents required for the development of Clinical Evaluation Plan and Report of Class I, IIa, IIb, III and implant devices.
- Responsible for data integrity, quality, and analysis of active and passive feedback data to keep an up-to-date Post-Market Surveillance system for medical devices that belongs to various risk classes.
- Contribution to R&D to establish proper technical documentation for the Master technical file of medical devices and expand the knowledge on the medical device life-cycle.
- Regularly enrolling in focus group meetings to transfer data from Clinical Evaluation Reports, and Post- Market Systems to Risk Management Procedure as required by Medical Device Regulation 2017/745.
- Set up medical device training for the rest of the cooperate teams to transfer the state-of-the-art knowledge on the medical device
