Director Biocompatibility

Abbott

5d•$172,000 - $344,000

About The Position

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. JOB DESCRIPTION: 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.

Requirements

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

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.