Lead Medical Device Toxicology & Biocompatibility

Alcon MX; Fort Worth (TX); On-site; USD 140,000 - 190,000; Full time

Job summary

Alcon Fort Worth is seeking a Medical Device Toxicologist to lead biological safety evaluations for devices and materials across the product lifecycle. The role requires designing risk-based strategies and translating toxicology data into regulatory positions.

You will oversee external laboratories and contribute to global regulatory submissions, applying ISO 10993 principles and integrating chemical and extractables data to support patient safety.

Qualifications

• MS or PhD in Toxicology or related discipline.
• Experience in medical device development and regulatory submissions.
• Knowledge of ISO 10993 standards and regulatory expectations.

Responsibilities

• Lead development of phase-appropriate biological evaluation strategies per ISO 10993.
• Author and review Biological Evaluation Plans and Reports with data integration.
• Oversee external labs, CROs, and regulatory interactions.

Skills

Biocompatibility

Regulatory strategy

Cross-functional leadership

External lab oversight

Toxicology interpretation

Communication in English

Education

MS or PhD in Toxicology

Bachelor’s degree or higher

Tools

Statistical analysis

Microsoft Office

Job description

Alcon Fort Worth is seeking a Medical Device Toxicologist to lead biological safety evaluations for devices and materials across the product lifecycle. The role requires designing risk-based strategies and translating toxicology data into regulatory positions.

You will oversee external laboratories and contribute to global regulatory submissions, applying ISO 10993 principles and integrating chemical and extractables data to support patient safety.