Director Biocompatibility

Director, Biocompatibility

Responsible for Biocompatibility support to the research & development of new medical device products as well as the maintenance of business activities by ensuring that adequate documentation exists for all the new and existing products to meet the existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series.

Principal 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.

Key Relationships :

The position interacts directly with functional groups including R&D groups, Preclinical, Regulatory, Analytical Chemistry, and Quality groups in the Abbott various business Divisions and CROs.

Qualifications :

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