Sr. Expert Consultant - Biocompatibility Expert - US

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.

Sr. Expert Biocompatibility Consultant

The Sr. 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 Responsibilities

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

Required Qualifications (Must-Have)

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.

Highly Desired

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

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.

Additional Information

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.)

Work Authorization: This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States at the time of hire and must be able to maintain work authorization without current or future visa sponsorship.

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.