Biological Safety Specialist

Develop and manage internal programs, with a global perspective, on biological safety risk assessment, testing plans / strategies, test parameters and methods through understanding and implementation of analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO 10993, FDA Guidance, and global regulatory requirement. Participate in design review meetings as a key member of new product design teams to assess products for biocompatibility and related biological safety concerns, including documentation of biological safety assessments, test plans, and associated reports. Actively represent Arthrex and the medical device industry through active involvement in international standards committees such as AAMI, ISO, and SOT. Function as subject matter expert for quality management system audits of Arthrex’s global laboratory service providers in accordance with applicable standards, e.g., ISO 13485, ISO/IEC 17025, and international regulatory directives.

According to JobzMall, the average salary range for a Biological Safety Specialist in 1370 Creekside Blvd, Naples, FL 34108, USA is $45,527 to $81,964. This range is based on salaries reported by job postings on the website.

Arthrex, an orthopedic medical device company, is a leader in product development, medical education and a pioneer in arthroscopy, having developed thousands of products and surgical procedures in orthopedic medicine worldwide.