Position Title: Biocompatibility / Toxicology Expert

• Schedule: Monday to Friday, 8:00 AM to 5:00 PM.
• Hybrid: Remote work on Mondays and Fridays.
• Pay Rate: $35/hr.

Role Overview:

The Biocompatibility / Toxicology Expert will support the Biocompatibility Team to ensure the biological safety and performance of Aesthetics Class III Absorbable Medical Devices (e.g., Dermal Fillers). This role involves study design, planning, coordination, and oversight to support product development and lifecycle management in biocompatibility and toxicology.

Key Responsibilities:

• Biological Evaluation Plan/Report Preparation: Design preclinical programs to assess and demonstrate the safety and performance of medical devices per ISO standards and regulatory requirements (e.g., EU MDR, US FDA, Chinese Regulations). Prepare Biological Evaluation Plans/Reports (BEP/BER) and Biological Risk Assessments (BRA).
• Non-Clinical Dossier Maintenance: Collaborate with Regulatory Affairs, Clinical Teams, and Production Sites for biocompatibility sustaining activities. Update Biological Evaluation Reports periodically and participate in Risk Management File (RMF) reviews.
• Support to Production Sites (US and EU): Conduct Biological Risk Assessments for process changes to Legacy Devices (e.g., equipment, raw material, supplier changes).
• Preclinical Biocompatibility Study Management: Plan, organize, monitor, and review GLP biocompatibility studies (chemical/biological tests) with external laboratories.
• Regulatory Compliance: Perform standard gap analyses and assess impacts on biocompatibility dossiers, studies, and documentation.

Technical & Functional Skills:

• Expertise in medical device biocompatibility.
• Knowledge of ISO 10993 series and biological evaluation standards.
• Fluent in English (French or German is a plus).
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Teams, SharePoint). Strong scientific, analytical, and organizational skills.
• Effective communicator (oral, written, and face-to-face).
• Team player who can also work independently.

Minimum Qualifications:

• Bachelor's degree or higher in biology, biochemistry, or chemistry.
• At least 1 year of experience in biocompatibility assessment of medical devices.
• Over 3 years of medical device experience.

Additional Details:

• Travel Requirements: None.
• Physical Requirements: Ability to sit, stand, and perform general office functions. Occasionally lift up to 25 pounds. Frequent bending, stooping, and reaching.