Research Specialist / Manager - Biocomp SME Conduct Biological Safety Risk Assessments on orthopedic device in accordance with ISO 10993 and EU MDR. Plan and manage in-vivo and in-vitro biocompatibility and chemical characterization studies that comply with industry standards (ASTM, ISO ) Write toxicological assessment and biological evaluation reports Preparation of responses to inquiries from regulatory agency (ex. FDA, BSI, CFDA, PMDA.) in a timely and thorough manner Work Collaboratively with scientists, engineers, and regulatory specialists in multidisciplinary project teams Proactively identify future biological safety challenges and develop strategies to address them Review and prepare procedures to keep pace with standards development Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings. Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings Help to develop and generate material for staff training and data presentations Provides support for key opinion leaders This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA. Overall Work Experience > 4 years. Relevant Experience on above areas > 2 years Educational qualification: Masters in chemistry/biochemistry/pharma with chemistry background/toxicologist Manufacturing Engineering, Mechanical engineering with manufacturing experience
CMR/ED/Animal Tissue evaluation experience REACH, ECHA, CAS Keywords Material evaluation for biocompatibility. (Raw material and contact material) Knowledge of manufacturing process of medical devices Extensive experience of biological evaluation + ISO 10993-1 standard Chemical analysis for any medical device Experience in toxicology and toxicological risk analysis (not neccesarily DABT/ERT certified) Material supplier coordination experience Educational Requirements :- 1) Biotechnology 2) ERT/DABT 3) Masters/ Ph.D. Required Skillset(s) Has shown outstanding competencies as subject matter expert in the following areas Current global toxicological guidelines (USP, JP, Ph., Eur., etc.) ISO 10993 standards EU MDR requirements Risk assessments of manufacturing contact materials Working knowledge of analytical chemistry Ability to work within a multidisciplinary team setting with good interpersonal skills Excellent oral and written communication skills Has a comprehensive record of external and internal training in area of competence Has proven competency in presenting subject matter to expert groups and key opinion leaders in a clear and convincing matter. Strong problem solving skills. Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner Demonstrates strong written and verbal communication skills including presentation skills. Has ability to tailor the information to the audience and answer with confidence and authority scientific questions Handles discussions of complex topics with confidence Demonstrates ability to discuss sensitive information with and tailor communication style to listeners' perspectives, including management, surgeons, and external contacts Responsibilities Conduct Biological Safety Risk Assessments on orthopedic device in accordance with ISO 10993 and EU MDR. Plan and manage in-vivo and in-vitro biocompatibility and chemical characterization studies that comply with industry standards (ASTM, ISO ) Write toxicological assessment and biological evaluation reports Preparation of responses to inquiries from regulatory agency (ex. FDA, BSI, CFDA, PMDA.) in a timely and thorough manner Work Collaboratively with scientists, engineers, and regulatory specialists in multidisciplinary project teams Proactively identify future biological safety challenges and develop strategies to address them Review and prepare procedures to keep pace with standards development Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings. Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings Help to develop and generate material for staff training and data presentations Provides support for key opinion leaders This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA. Shows leadership skills and initiative
