Highridge Medical · 1 day ago
Biocomp and Toxicology Manager
Westminster, CO
Full-time
Onsite
Senior Level
5+ years expHighridge Medical is seeking a Medical Device Biocompatibility & Toxicology Manager responsible for ensuring the biological safety of medical devices throughout their lifecycle. This role involves toxicological risk assessment, biocompatibility strategy development, and regulatory support, while also providing scientific leadership and managing a biosafety team.
ManufacturingMedical
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
Qualification
Required
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
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
Preferred
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
Company
Highridge Medical
Highridge Medical is a medical device company focused on designing and commercializing novel and proprietary products and solutions. It is a sub-organization of H.I.G. Capital.
1001-5000 employees
H1B Sponsorship
Highridge Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2023-12-18Acquired
Recent News
2026-01-21
2025-11-27
Company data provided by crunchbase