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 Consultant

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.

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 a...