Biocompatibility Director

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

We are seeking a highly experienced Biocompatibility Director to join our team. As a key member of our organization, you will be responsible for ensuring the biocompatibility of our medical devices, ensuring compliance with regulatory requirements, and providing expert guidance to our research and development teams.

• Manage direct staff conducting biocompatibility evaluation of medical devices across multiple divisions of Abbott
• Develop and implement biocompatibility resourcing strategy to support business divisions' needs
• Conduct safety assessments for new product development and provide solutions for the evaluation of safety risk for manufacturing and life cycle management challenges
• Author and provide guidance on risk assessments, 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 to ensure appropriate planning and execution of risk assessments and required testing

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

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please contact us at [insert contact information].