Skills

• PHARMACEUTICAL MEDICAL WRITING
• RADIOPHARMACEUTICALS
• ORGANIC CHEMISTRY
• DOCUMENTATION

Additional

• MEDICAL DEVICES
• MAINTENANCE
• SAMPLE PREPARATION
• CLINICAL SAFETY
• MARKETING
• BIOLOGICAL SCIENCES
• FDA
• DESIGN CONTROL
• RISK ASSESSMENT
• WRITING TECHNICAL
• INSTRUMENTATION
• LABORATORY
• AUDITING
• LIFE SCIENCES
• ANALYTICAL CHEMISTRY
• CHEMICAL TESTING
• CHEMISTRY
• TOXICOLOGY
• FTIR
• ICP
• POLYMERS
• HPLC

Duties:

CMC Scientist

Key Responsibilities Knowledgeable in biocompatibility standards and requirements for marketing medical devices globally (USA, Europe and other countries) Collaborate effectively with team members from various disciplines globally to develop biocompatibility testing strategies to qualify medical device product Review, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility compliance and appropriate Regulatory and Quality (e.g. MDR) compliance. Work closely with supervisor to determine potential regulatory risks associated with proposed biocompatibility test strategy and reviewing test protocols from contract labs Collaborate with Biocompatibility team members for alignment with testing strategies Coordinate testing through outside laboratories by preparing test samples, submission forms, monitor chemical testing or biological studies, review reports generated by outside laboratories and generate final summary report Author Toxicological Risk Assessment Reports for extractables/leachables, Biocompatibility Risk Assessment Reports for CE Mark and US FDA 510 K Submissions Work must show accuracy, attention to detail, completeness of documentation, and be well organized. Support interactions with regulatory bodies related to available biocompatibility data for a product Support development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files Appropriately prioritize assignments to meet project schedules Responsible for meeting scope and timelines of Biocompatibility deliverables to project teams

Skills:

Understanding of principles, and techniques of toxicology and biocompatibility 3-5 years of experience in medical device industry or biocompatibility research organization working on biocompatibility of medical device Deep working knowledge of ISO 10993 standards for biocompatibility Ability to coordinate work through outside service laboratories (e.g. extractables/leachables testing and non-clinical safety studies) Experience with sample preparation/extraction/ separation techniques for material analyses Experience in polymers, analytical chemistry Experience in instrumentation analysis – e.g. FTIR, HPLC, GC, IC, ICP-MS, GC/MS spectroscopic techniques Experience interpreting laboratory data and working with mathematical concepts relevant to chemical or biological testing Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines and writing technical reports, toxicological risk assessment or biocompatibility evaluations Experience working in Design Control environment; Auditing Skills, Knowledge of quality systems and regulatory submissions Strong oral and written communication skills Ability to multitask and track multiple projects at various stages Attention to detail; Critical thinking skills to Interpret available data and recommend strategies to resolve technical challenges. Strong computer and general software skills

Education:

Bachelors Degree in Biological Sciences or Toxicology or Chemistry with courses in Life Sciences