Expert Consultant - Biocompatibility Expert - US

About the role

The Expert Biocompatibility Consultant is a senior scientific contributor responsible for leading biocompatibility assessments and biological evaluations for medical device products in global, highly regulated environments. This role operates at the assessment, strategy, and advisory level and is ideal for professionals who have already built depth in biocompatibility and now influence decisions through technical judgment, documentation, and communication.

Responsibilities

• Lead development and authorship of biocompatibility assessments, biological evaluations, and risk assessments
• Perform and synthesize literature-based evaluations of materials, compounds, and device use
• Apply ISO 10993 principles and FDA expectations to support regulatory submissions and decision-making
• Author opinion memos and other patient safety–focused technical documentation
• Partner closely with clients, internal technical teams, and leadership to develop defensible, regulator-ready assessments that safeguard patient health and support product approval worldwide
• Serve as a subject-matter expert during client discussions and project initiation
• Clearly communicate scientific and regulatory rationale to technical teams, clients, and senior stakeholders
• Collaborate cross-functionally to deliver integrated, high-quality project outcomes
• Support proposal development and scope review in partnership with project leadership
• Participate in development of international standards
• Deliver technical presentations at conferences, seminars, webinars, and industry forums
• Contribute to continuous improvement of internal processes, templates, and best practices

Qualifications

• Significant experience in biocompatibility assessment within a medical device environment
• Demonstrated expertise authoring assessments, evaluations, SOPs, and regulatory-facing documents
• Strong working knowledge of FDA-regulated environments and applicable standards (ISO 10993)
• Exceptional technical writing and verbal communication skills, including comfort presenting to senior and executive audiences
• Proven ability to independently own projects and operate as a trusted expert

Desired Abilities

• Ability to bridge Biocompatibility and Medical Toxicology (biocompatibility expertise is primary)
• Experience engaging with or supporting interactions with regulatory agencies
• Interest in external-facing work, standards involvement, and scientific thought leadership

Education & Experience Requirements

• Bachelor’s degree in relevant science with 7 years’ relevant experience
• OR
• MS/PhD degree in related emphasis with 5 years’ relevant experience
• Strong understanding and ability to apply biological evaluation principles preferred
• Relevant fields include: Biology, Chemistry, Toxicology, Biomedical Engineering, Materials Science, Biotechnology, Pharmacology, or Engineering

Additional Information

• Work Arrangement: Fully remote (onsite presence as needed based on location)
• Travel: Approximately 20%, including occasional international travel