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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.