Associate Director, Toxicology & Biocompatibility, R&D - MedTech Surgery

Associate Director, Toxicology & Biocompatibility (R&D - MedTech) - Raritan, NJ (commutable distance). Flex/Hybrid: 3 days/week on-site; no remote.

Responsibilities

• Lead development and execution of toxicology and biocompatibility evaluations for MedTech Surgery medical device products.
• Provide people leadership/development for Toxicology & Biocompatibility SMEs; drive strategy, workflow, performance, and compliance.
• Design/interpret in vitro and in vivo toxicology studies; identify and mitigate biological safety risks.
• Advance capabilities via technology/process improvements; enhance chemical characterization and biocompatibility assessments.
• Collaborate with R&D, Regulatory Affairs, and supply chain to integrate insights into product development.
• Prepare/present reports and regulatory submissions; communicate complex scientific data.
• Liaise with internal/external stakeholders; support audits and notified body/regulatory requests.

Qualifications/Requirements

• MS or PhD in Toxicology, Pharmacology, Biological Sciences, or related field.
• 4+ years leading technical SME teams.
• 8-10+ years toxicology/biocompatibility experience in medical devices/pharma (medical device experience strongly preferred).
• Expertise in toxicological safety assessments and converting risk assessments into regulatory documents.
• Experience with ISO 10993/14971/13485 and interactions with US FDA/OUS authorities.
• Required: experience with absorbable biomaterials (implantable devices), including degradation and toxicokinetics.

Preferred Skills

• Lead process development in regulated medical device environments; lab capability/data systems development.
• Cross-functional collaboration, technical mentorship, strong communication, analytical problem-solving; travel up to 10%.

Benefits (time off)

• Vacation (120 hrs/yr)
• Sick (40 hrs/yr; CO/Washington higher)
• Holiday pay incl. floating holidays (13 days/yr)
• Work/Personal/Family time (up to 40 hrs/yr)
• Parental leave (480 hrs/yr)
• plus additional specified leaves (bereavement, caregiver, volunteer, military spouse time-off)