Associate Director - Biocompatibility & Toxicology

Associate Director - Biocompatibility & Toxicology

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Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major product groups include aortic stent grafts, surgical sealants, On‑X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has more than 1,400 employees worldwide, with sales representation in over 100 countries.

The company operates manufacturing facilities in Atlanta, Georgia;
Austin, Texas; and Hechingen, Germany, and has sales and distribution offices throughout Europe, Asia, and South America. For additional information, visit our website at

Lead and support the global biocompatibility program for all sustaining and new products, focusing on biological safety testing strategy development; toxicological and biological risk굴 assessments; ISO 10993 process and documentation improvement; and optimization of chemical characterization testing.

• Serve as a senior subject matter expert (SME) in biocompatibility, chemical characterization, and toxicology, with a focus on developing testing strategies for biological safety evaluations.
• Author, review, and facilitate biocompatibility and chemical characterization test plans, assessments, and reports; assess data to support business and regulatory objectives.
• Consult on safety testing strategies for new product development (NPD) and investigational devices, including regulatory implications.
• Provide deep scientific analysis of safety data, including toxicological risk assessments and gap analyses, aligned with current standards and regulatory guidance.
• Write and maintain SOPs to ensure the adequacy of biological, chemical, and toxicological documentation.
• Support internal teams by addressing biocompatibility and toxicology issues, resolving problems, and maintaining communication across functions.
• Advise on global regulatory requirements (US, EU, APAC, etc.) for medical device submissions, and assist with responses to regulatory agency queries.
• Participate in core teams, design and risk reviews, and support record keeping for biological safety assessments and test documentation.
• Lead and contribute to biocompatibility training programs across functional groups based on current standards and regulations.
• Maintain expertise in applicable standards and industry practices related to medical device biological safety.
• Collaborate with cross‑functional teams including R&D, Regulatory, Analytical Chemistry, and Quality to ensure timely project execution.
• Manage change control activities and support internal/external audits by maintaining biocompatibility readiness documentation.
• Act as liaison with CROs/vendors, including oversight of SOWs, POs, and related documentation.
• Lead cost‑ and time‑saving initiatives, including developing in‑house in vitro test capabilities.
• May lead special projects or corporate initiatives as assigned.
• Lead and manage direct reports in the R&D team, specifically those with biological safety and chemical characterization responsibilities. Set clear goals, provide regular feedback, conduct performance reviews, and foster a positive team environment. Managers would also delegate tasks effectively, mentor team members, and address any challenges or barriers impacting employee performance.
• Create and manage biological safety and chemical characterization testing budgets effectively, including but not limited to AOP planning (operating and capital expenses), resource planning, consulting and testing costs. Plan sample Statistical counts for testing.

• 10+ years experience at testing CRO and/or medical device manufacturer highly preferred.
• A MS degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with a BS and 15+ years of related experience.
• A PhD degree in Toxicology or…