Expert Biocompatibility Consultant

Sotera Health•Taylorsville, UT

4h•Remote

About The Position

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. 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.

Requirements

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
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
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.)

Nice To Haves

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
Strong understanding and ability to apply biological evaluation principles preferred.

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
Provide peer review and technical guidance on complex or high-risk projects
Author opinion memos and other patient safety–focused technical documentation
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 international standards development
Deliver technical presentations at conferences, seminars, webinars, and industry forums
Contribute to continuous improvement of internal processes, templates, and best practices
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)
Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
Know and follow company policies and procedures.
Complete required training on time.