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.

RESPONSIBILITIES:

• Manage direct staff conducting biocompatibility evaluation of medical devices across multiple divisions.
• Develop and implement a biocompatibility resourcing strategy to update support of the business division’s needs.
• Conduct safety assessments for new product development and provide solutions for the evaluation of safety risks for manufacturing and life cycle management challenges.
• Serve as a core team project member.
• Author and provide guidance on risk assessments (products/materials, impurities, leachable and extractable), author regulatory documents, and interact with Health Authorities.
• Responsible for meeting the scope and timelines of Biocompatibility deliverables to project teams
• Review, assess, and address any gaps in 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.

EDUCATION AND EXPERIENCE QUALIFICATIONS:

• The position requires a Master’s or Ph.D. 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 EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).
• Experience in managing nonclinical safety studies at external facilities.
• Experience working in a Design Control environment.
• Strong computer and general software skills
• Strong oral/written communication skills