[Hiring] Expert Biocompatibility Consultant @Sotera Health

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.

You will partner closely with clients, internal technical teams, and leadership to develop defensible, regulator-ready assessments that safeguard patient health and support product approval worldwide.

Biocompatibility & Scientific Leadership

• 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
• Provide peer review and technical guidance on complex or high-risk projects
• Author opinion memos and other patient safety–focused technical documentation

Client & Consulting Engagement

• 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

Thought Leadership & Standards

• Participate in international standards development
• Deliver technical presentations at conferences, seminars, webinars, and industry forums
• Contribute to continuous improvement of internal processes, templates, and best practices

• 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

This role is not intended for early-career professionals or hands-on testing-focused profiles.

• 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

• Bachelor’s degree in a relevant scientific discipline with 7+ years of relevant experience
  OR
• MS or PhD in a related field with 5+ years of relevant experience

Relevant fields include:
Biology, Chemistry, Toxicology, Biomedical Engineering, Materials Science, Biotechnology, Pharmacology, or Engineering.

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

The Expert Biocompatibility Consultant will develop the initial draft of related projects to safeguard global health. This will include obtaining all necessary information from the client and performing the necessary literature research. This information will then be summarized in a technical format for the project and submitted for peer review. The Expert Biocompatibility Consultant will also assist with peer review as needed. The Expert Biocompatibility Consultant will participate in development of international standards, and will provide technical presentations at conferences and seminars.

Education and experience requirements:
• Bachelor’s degree in relevant science with 7 years’ relevant experience or an MS/PhD degree
in related emphasis with 5 years' relevant experience.
• Strong understanding and ability to apply biological evaluation principles preferred.

Consulting
• Serve as primary writer on documents
• Peer review team documents
• Join calls as expert to support initial client discussions
• Review quotes with project manager and team manager
• Prepare templates and write risk assessments
• Work cross-functionally with other departments on projects where collaboration is needed
• Communicate with the client to obtain additional information for projects or related testing
• Perform literature research on materials and compounds
• Build and implement process improvements
• Know and follow the Nelson service standard
• Review and write assessments and other related documents as needed (i.e. Opinion Memos
for patient safety)

Regulatory Compliance
• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
• Know and follow company policies and procedures.
• Complete required training on time.

Competencies of this position
• Good project management skills
• Owning projects with customers
• Taking on STAT projects
• Excellent communication skills
• Leading phone calls
• Excellent technical writing skills and expertise
• Write regulatory responses with guidance
• Attention to detail
• Able to handle simple to moderately difficult assignments
• Time management – must be able to respond to voicemails, emails, and other
communications in a timely manner
• Able to multi-task and be self-motivated
• Knowledge Microsoft Office applications (Word, Excel, PowerPoint, Outlook, etc.)