Clinical Evaluation Specialist

Bıçakcılar Tıbbi Cihazlar San. ve Tic. A.Ş.

Bıçakcılar is the leading disposable medical device and medical device manufacturer in Esenyurt, Istanbul who brand has gained wide acceptance and has established a tradition of sustained reliability and customer satisfaction. 

We are seeking a “Clinical Evaluation Specialist” that will add value to our company with below qualifications. Specialist will have an advanced in-depth knowledge of medical writing and will be responsible for developing Clinical Evaluation Reports (CERs) and assessing the need for product change CERs. 

This individual will have demonstrated significant expertise in partnering with clinical research, regulatory affairs, quality/reliability, product development, and biostatisticians to develop schedules and timely execute tasks. The individual will have demonstrated the ability to provide solutions to a variety of problems of moderate scope and complexity and ensures that solutions are consistent with objectives. The individual will have a broad expertise in collaborating on a number of clinical and regulatory documents. 

The role includes management of the clinical evidence report writing process to ensure compliance to regulations and expectations of Regulatory Bodies.  

Job Description: 

 • Analyze and synthesize vast amount of pre-clinical data, risk management assessments, published literature, clinical investigation results and field performance data in order to evaluate product safety and performance. 

• Interface with key functional areas (eg. Product core teams, clinical team, EU and US regulatory, marketing risk management group) to obtain necessary information and documents required for the development of CERs. 

• Develop therapeutic and device operation knowledge and apply this knowledge to clinical assessment and development of evaluation reports for corresponding product/s. 

• May participate and/or facilitate meetings with health care professionals, consultants and internal scientific or tactical committees. 

• Provide input and feedback to product core teams/members/teams in the determination of appropriate clinical evaluation strategy, and may provide input and direction to project teams in order to arrive at a sound clinical evaluation. 

• May interface with regulatory agencies to discuss details of the clinical evaluation report, including clinical assessment results 

• Collaborate with cross-functional team to assure high quality and successful completion of deliverable 

• Critically evaluate project progress and metrics. May collaborate with cross functional team to identify risks and mitigation plans 

• Manage project schedule, timelines and deliverables 

• Participate in process improvement initiatives 

• Other relevant duties as required