Biocomp and Toxicology Manager

HighRidge Medical LLC•Westminster, CO

23d

About The Position

Medical Device Biocompatibility & Toxicology Manager is responsible for ensuring the biological safety of medical devices throughout the product lifecycle. This role integrates toxicological risk assessment, biocompatibility strategy development, and regulatory support in accordance with global standards such as ISO 10993. Acting as both a technical expert and internal Subject Matter Expert (SME), this role provides scientific leadership, guides material selection, oversees testing, manages biosafety team and supports regulatory submissions to ensure devices are safe and compliant for human use.

Requirements

Strong expertise in the implementation of ISO 10993 series; FDA guidance documents is highly desirable.
General knowledge of ISO19227 and 11137 requirements.
Working knowledge of FDA and EU MDR regulatory requirements.
Strong analytical and critical-thinking skills to assess risk and interpret data.
Demonstrate excellent technical written and verbal communication skills for quality documentation and regulatory interactions.
Ability to effectively and professionally provide scientific leadership when working with cross-functional teams.
Ability to deliver and meet results driven deadlines.
Demonstrate excellent team management and work planning skills.
Proven and dynamic leader who positively influences their team through challenging internal and external customer demands.
Bachelor’s, in Toxicology, Biomedical Engineering, Pharmacology, Materials Science, or a related life science field required.
Minimum of 5 years of experience in medical device biocompatibility and/or toxicology

Nice To Haves

Master’s, or PhD in Toxicology, Biomedical Engineering, Pharmacology, Materials Science, or a related life science field strongly preferred.
Master’s or PhD degrees preferred
Experience of Life Sciences industry preferred

Responsibilities

Develop, review, and approve biocompatibility evaluation plans and reports (BEPs/BERs) in alignment with ISO 10993 and related standards.
Design and execute biological safety testing strategies based on device materials, patient contact, and intended use.
Perform toxicological risk assessments using chemical characterization, extractables and leachables (E&L) data, and analytical chemistry results.
Evaluate potential patient risks from leachable and extractable compounds and provide scientifically sound justifications.
Prepare and review biological safety and toxicology documentation for regulatory submissions (FDA, EU MDR, and other global authorities).
Support responses to regulatory agency questions related to biocompatibility and toxicology
Collaborate with R&D, manufacturing, quality, and regulatory teams to assess the safety impact of new materials, designs, and process changes.
Provide guidance to the organization on material selection and design decisions to mitigate biological risk early in development.
Manage planning and timely testing execution with testing laboratories for biocompatibility studies.
Review study protocols and reports for scientific rigor, regulatory compliance, and data quality.
Serve as the internal subject matter expert for biological safety and toxicology.
Manage and mentor biosafety team on biocompatibility principles, regulatory expectations, and project deliverables.
Manage cleaning and sterilization team, including providing guidance on final cleaning and gamma/e-beam sterilization of products that are contract manufactured.