Senior Biocompatibility & Toxicology Scientist

MillenniumSoft Inc; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

MillenniumSoft Inc. seeks a Senior Staff Scientist II to lead preclinical safety and biocompatibility programs for medical devices in a GLP environment. The role focuses on regulatory-driven evaluation and collaboration with global teams in CPDT.

The position requires strong toxicology expertise, literature review, and the ability to design strategies, sponsor studies, and ensure EU MDR remediation as needed.

Qualifications

• Bachelor’s degree in toxicology or closely related field with 8+ years of pre-clinical medical device development experience; or Master’s with 5+ years; or PhD with 2+ years.
• Board certification in toxicology preferred (e.g., DABT, ERT)
• Experience in a GLP preclinical environment preferred.

Responsibilities

• Design, execute and interpret preclinical safety and biocompatibility studies per regulatory requirements.
• Serve as Sponsor Representative for biocompatibility and chemistry studies.
• Support EU MDR remediation efforts and generate biocompatibility evaluation reports.
• Maintain historical databases and perform data searches.

Skills

Biology

Toxicology

Biocompatibility

Analytical chemistry

Regulatory knowledge

Communication

Teamwork

Multitasking

Education

Bachelor’s degree in toxicology or closely related field

Master’s degree in toxicology or closely related field

PhD in toxicology or closely related field

Board certification (DABT, ERT)

Job description

MillenniumSoft Inc. seeks a Senior Staff Scientist II to lead preclinical safety and biocompatibility programs for medical devices in a GLP environment. The role focuses on regulatory-driven evaluation and collaboration with global teams in CPDT.

The position requires strong toxicology expertise, literature review, and the ability to design strategies, sponsor studies, and ensure EU MDR remediation as needed.