Director Biocompatibility

Director, Biocompatibility Position Summary

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.

• 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.

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.

• 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

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

EEO is the Law link – English:

EEO is the Law link – Español:

From

The base pay for this position is $ – $. In specific locations, the pay range may vary from the range posted.