The
Medical Device Toxicologist will serve as a scientific leader and subject matter expert for the biological safety evaluation of medical devices, combination products, materials, and components across the product lifecycle. The role will develop risk-based biocompatibility strategies, integrate chemical and biological evidence, and translate complex toxicology data into clear product-safety conclusions and global regulatory positions. The successful candidate will pair medical device toxicology expertise with toxicology judgment, strategic problem solving, cross-functional leadership, and effective oversight of external laboratories and consultants.
This role is on-site in Fort Worth, Texas and would include:
- Lead development and execution of phase-appropriate, risk-based biological evaluation strategies for new and existing medical devices, combination products, components, materials, manufacturing changes, and product modifications.
- Author and critically review Biological Evaluation Plans and Biological Evaluation Reports that integrate device categorization, nature and duration of contact, chemical characterization, toxicological risk assessment, existing data, and biological testing.
- Apply ISO 10993 principles, including ISO 10993-1, to determine relevant biological endpoints and establish scientifically justified testing, read-across, bridging, or testing-waiver strategies.
- Integrate device extractables and leachables data, chemical and material characterizations, and exposure information with toxicological hazard data to assess patient risk and support product safety conclusions.
- Develop toxicological risk assessments for identified constituents and establish health-based exposure limits using relevant toxicology principles, weight-of-evidence methods, and computational toxicology tools.
- Serve as the medical device toxicology and biocompatibility subject matter expert on product development, lifecycle management, remediation, and regulatory-response teams.
- Critically evaluate complex or conflicting data, identify evidence gaps and product-safety risks, and recommend pragmatic, science-based paths forward that balance patient safety, regulatory expectations, program timing, and business needs.
- Lead biocompatibility workstreams and integrated project plans, including scope, milestones, dependencies, timelines, budgets, risks, and decision points.
- Contribute to global regulatory submissions and responses by authoring, reviewing, and defending medical device toxicology and biocompatibility content.
What You'll Bring to Alcon:- Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; B.S. +3 yrs; M.S.+2 yrs; PhD +0 yrs).
- The ability to fluently read, write, understand and communicate in English.
- 5 Years of Relevant Experience
Preferred Qualifications:- MS or PhD in Toxicology or a related discipline (e.g., Pharmacology, Biomedical Sciences, Pharmaceutical Sciences, Environmental Health Sciences, etc.).
- Relevant experience in pharmaceutical and/or medical device development (industry, postdoctoral, or equivalent).
- Direct experience with medical device and/or combination product development across early development, design changes, registration, and postmarket lifecycle management.
- Experience preparing regulatory submission content and responding to questions from FDA and other global regulatory authorities.
- Knowledge of computational toxicology, including structure-activity relationship approaches, read-across, and weight-of-evidence assessment.
- Excellent written and verbal communication skills.
- Knowledgeable of pertinent sections of REACH, the EU MDR, and Proposition 65 (hazardous substances regulations) as well as ICH and FDA Guidance Documents (e.g., application of Threshold of Toxicological Concern [TTC] and use of ISO 10993-1 and 10993-17 standards in risk assessments, etc.)
- Proficient with statistics and Microsoft suite of office applications.
- Demonstrated experience and/or in-depth knowledge developing medical device biological evaluation strategies and applying ISO 10993 standards and related global regulatory expectations.
- Experience interpreting chemical characterization and toxicological risk assessment data in support of medical device safety.
- Experience overseeing external laboratories, CROs, consultants, or vendors and providing scientific oversight of studies and deliverables.
- Demonstrated scientific leadership, strategic problem solving, sound judgment, and the ability to lead cross-functional projects in a matrixed environment.
- Excellent written and verbal communication skills, including the ability to influence decisions and present complex scientific conclusions clearly.
- Ability to work independently, manage multiple priorities, and rapidly learn new products, systems, and processes.
