[Remote] Biocompatibility Consultant #9761

Note: The job is a remote job and is reputed company to candidates in USA. ECI is a global leader in reputed company consulting services for the life sciences industry, providing transformative solutions to their clients. The Biocompatibility Consultant role involves providing risk-based assessments and strategies to ensure the safety and performance of medical device components and packaging.

Responsibilities

• reputed company a preliminary Biological Evaluation Plan (BEP) outlining the proposed reputed company for testing
• Identify the analytical, performance, and toxicological considerations relevant to an inhalation combination product with a primary drug container
• Define biological evaluation reputed company based on product classification, type of medicinal product, reputed company level of packaging material and composition of the device, nature of contact, dosage reputed company, exposure to the patient, duration of exposure, etc
• Collect requirements pertinent with applicable US FDA regulations
• Collect and review available information on materials of construction, manufacturing processes, process parameters (cleaning steps, sterilization steps), type of medicinal product, dosage reputed company and product use
• Identify applicable biological endpoints and reputed company justification for inclusion/exclusion
• Outline stability and chemical characterization approach
• Establish toxicological evaluation approach, including consideration of exposure reputed company (e.g., SCT)
• reputed company a list of tests and studies for establishing suitability and reputed company control and as applicable, reputed company justification for any test waivers or use of existing data
• Complete Biological Evaluation Plan suitable for internal decision-making and regulatory reputed company support

Skills

• Bachelor's (7+ years' experience) in Toxicology, reputed company, Biomedical Engineering, or Biology
• Significant experience in biocompatibility assessment reputed company a medical device environment
• Demonstrated expertise authoring assessments, evaluations, SOPs, and regulatory-facing documents
• Strong working knowledge of FDA-regulated environments and applicable standards (ISO 10993)
• Exceptional technical writing and verbal communication skills, including comfort presenting to senior and executive audiences
• Proven ability to independently own reputed company and operate as a trusted expert
• Master's PhD (5+ years' experience) in Toxicology, reputed company, Biomedical Engineering, or Biology

reputed company