Biocompatibility Engineer İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
We are looking for a "Biocompatibility Engineer" for one of our global & multinational customer who operates in the medical sector.
JOB DESCRIPTION:
Work closely with program/project cross-functional teams to provide biocompatibility assessments, strategy and deliverables in compliance with global regulatory requirements such as ISO 10993.
Plan and manage the impact assessment of manufacturing, supplier, and material changes to medical devices and new products with patient contacting components to ensure biological safety and product sustainability.
Identify and assess business/technical project risks and recommend/influence contingency plans for risk mitigation. Apply technical expertise to solve complex biocompatibility problems as related to the ISO 10993 standards and regulatory authority requirements for product safety
Support the creation and defense of submissions to global Regulatory Authorities.
Collaborate and clearly communicate with internal and external stakeholders (e.g., Board Certified Toxicologists and Contract Research Organizations (CROs) to ensure appropriate planning and execution of risk assessments and required testing.
Review, interpret, and summarize raw data from external stakeholders on reports and documents and biological risk assessments using sound scientific principles.
Ensure that testing meets all international & domestic test requirements according to ISO, FDA, EU, MDR, GLP, Japan, and APAC counties
Conduct quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations.
Support on-site and off-site Regulatory Authority audits to for product that may be sold in worldwide markets
Maintain biocompatibility assessment documents for each production. Ensure the assessment documents are in accordance with the latest version of the standards.
REQUIREMENTS:
Functional expert in the principles of Biocompatibility Risk assessment.
Knowledgeable of applicable ASTM, ISO, FDA, EN, Japan, and APAC standards with an in-depth understanding of ISO 10993 biocompatibility standards
Experience in pre-clinical science/Biocompatibility testing in medical device, pharmaceutical, or biotechnology industries
A detailed understanding of the product development process is preferred
Effective project management and communications skills in a dynamic, matrixed, geographically diverse business environment to meet deadlines and deliver on commitments. Effective in leveraging and/or engaging others to accomplish projects.
Effectively manages relationships and projects with external stakeholders (e.g. Contract Research Organizations)
Effective in accurately scoping projects and considering the full impact of decisions and actions taken and in balancing multiple priorities and project deliverables
Establishes and maintains effective working relationships with coworkers, managers and cross functional teams.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Proficient with statistics and Microsoft suite of office applications
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