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. Our 114,000 colleagues serve people in more than 160 countries.

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.

Principal Responsibilities

Manage direct staff conducting biocompatibility evaluation of medical devices across multiple divisions of AbbottDevelop and implement biocompatibility resourcing strategy to update support of business divisions needsConduct safety assessment for new product development and provide solutions for the evaluation of safety risk for manufacturing and life cycle management challengesServe as core team project memberAuthor 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 teamsReview, 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 FilesManage relevant standards and regulationsMentor staffCollaborate 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

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 devicesExpert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993Experience working with global regulations and requirements, especially the Medical Device Regulations (MDR).Experience in managing nonclinical safety studies at external facilitiesExperience working in Design Control environmentStrong computer and general software skillsStrong oral/written communication skills

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

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

From

The base pay for this position is $162,000.00 – $324,000.00. In specific locations, the pay range may vary from the range posted.