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Abbott · 1 day ago

Director Biocompatibility

Santa Clara, CA

Full-time

Onsite

Director/Executive

$172K/yr - $344K/yr

10+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Director of Biocompatibility is responsible for providing biocompatibility support for the research and development of new medical device products and ensuring compliance with regulatory requirements.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Manage direct staff conducting biocompatibility evaluation of medical devices across multiple divisions of Abbott

Develop and implement biocompatibility resourcing strategy to update support of business divisions needs

Conduct safety assessment for new product development and provide solutions for the evaluation of safety risk for manufacturing and life cycle management challenges

Serve as core team project member

Author and provide guidance on risk assessments (products/materials, impurities, leachables and extractables), author regulatory documents, and interact with Health Authorities

Responsible for meeting scope and timelines of Biocompatibility deliverables to project teams

Review, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility and appropriate Regulatory and Quality compliance

Oversee development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files

Manage relevant standards and regulations

Mentor staff

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

Qualification

Biocompatibility expertiseISO 10993 knowledgeRegulatory complianceNonclinical safety studiesDesign Control experienceSoftware skillsCommunication skills

Required

The position requires a Master or PhD degree in biology, biochemistry, toxicology, analytical chemistry or materials science, preferably with a specialism relating to medical devices

The position requires a minimum of 10 years in Biocompatibility for medical devices

Expert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993

Experience working with global regulations and requirements, especially the Medical Device Regulations (MDR)

Experience in managing nonclinical safety studies at external facilities

Experience working in Design Control environment

Strong computer and general software skills

Strong oral/written communication skills