Senior Lead, Biocompatibility & Toxicology

Artivion; Kennesaw (GA); On-site; USD 140,000 - 190,000; Full time

Job summary

Artivion, Inc. is seeking a senior leader to spearhead the global biocompatibility program for sustaining and new products, focusing on biological safety testing strategy development, toxicology risk assessments, and regulatory readiness across US, EU, and APAC.

You will author and review test plans, collaborate with R&D, Regulatory, and Quality, manage CROs, and lead biocompatibility training while ensuring GLP/nGLP compliance.

Qualifications

• 10+ years experience at testing CRO and/or medical device manufacturer.

Responsibilities

• Lead and support biocompatibility, chemical characterization, and toxicology programs.

Skills

Biocompatibility

Toxicology

Regulatory strategy

Risk assessment

Project management

CRO/vendor oversight

Leadership

Written communication

Cross-functional collaboration

ISO 10993

Education

MS in Toxicology or related field

BS with 15+ years experience in toxicology/biocompatibility

PhD in Toxicology or related field; DABT preferred

Job description

Artivion, Inc. is seeking a senior leader to spearhead the global biocompatibility program for sustaining and new products, focusing on biological safety testing strategy development, toxicology risk assessments, and regulatory readiness across US, EU, and APAC.

You will author and review test plans, collaborate with R&D, Regulatory, and Quality, manage CROs, and lead biocompatibility training while ensuring GLP/nGLP compliance.