Expert Biocompatibility Consultant

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.Expert Biocompatibility ConsultantThe 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.Key ResponsibilitiesBiocompatibility & Scientific LeadershipLead development and authorship of biocompatibility assessments, biological evaluations, and risk assessmentsPerform and synthesize literature-based evaluations of materials, compounds, and device useApply ISO 10993 principles and FDA expectations to support regulatory submissions and decision-makingProvide peer review and technical guidance on complex or high-risk projectsAuthor opinion memos and other patient safety–focused technical documentationClient & Consulting EngagementServe as a subject-matter expert during client discussions and project initiationClearly communicate scientific and regulatory rationale to technical teams, clients, and senior stakeholdersCollaborate cross-functionally to deliver integrated, high-quality project outcomesSupport proposal development and scope review in partnership with project leadershipThought Leadership & StandardsParticipate in international standards developmentDeliver technical presentations at conferences, seminars, webinars, and industry forumsContribute to continuous improvement of internal processes, templates, and best practicesRequired Qualifications (Must-Have)Significant experience in biocompatibility assessment within a medical device environmentDemonstrated expertise authoring assessments, evaluations, SOPs, and regulatory-facing documentsStrong 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 audiencesProven ability to independently own projects and operate as a trusted expertThis role is not intended for early-career professionals or hands-on testing-focused profiles.Highly DesiredAbility to bridge Biocompatibility and Medical Toxicology (biocompatibility expertise is primary)Experience engaging with or supporting interactions with regulatory agenciesInterest in external-facing work, standards involvement, and scientific thought leadershipEducation & ExperienceBachelor’s degree in a relevant scientific discipline with 7+ years of relevant experience ORMS or PhD in a related field with 5+ years of relevant experienceRelevant fields include: Biology, Chemistry, Toxicology, Biomedical Engineering, Materials Science, Biotechnology, Pharmacology, or Engineering.Additional InformationWork Arrangement: Fully remote (onsite presence as needed based on location)Travel: Approximately 20%, including occasional international travelThe 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 degreein 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 Memosfor 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 othercommunications in a timely manner Able to multi-task and be self-motivated Knowledge Microsoft Office applications (Word, Excel, PowerPoint, Outlook, etc.)Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.