Business Title: Toxicology Expert
Location: Raleigh, NC
Job Type: 6+ months contract
The Biocompatibility / Toxicology Expert will support the Biocompatibility Team to ensure the evaluation of biological safety and performance of Aesthetics Class III Absorbable Medical Devices for Aesthetics purpose (Dermal Fillers). The person will be responsible for study design, planning, coordination and overseeing of her/his activities to support product development and life-cycle management in terms of biocompatibility and toxicology.
Job Responsibilities:
- Preparation of biological evaluation plan/report (BEP/BER) for projects/devices
- Design preclinical programs to evaluate and demonstrate the safety and performance of medical devices in accordance with ISO standards and regulatory requirements (incl. but not limited to EU MDR, US FDA, Chinese Regulations) and internal quality procedures
- Preparation of Biological Evaluation Plan/Report and/or Biological Risk Assessments
- Maintenance of Non-Clinical Dossiers of Medical Devices
- Cross-collaboration with Regulatory Affairs, Clinical team, and Production sites for the support to sustaining activities with regards to biocompatibility
- Maintenance activities include, but are not limited to, periodic update of BER, participate and review of Risk Management File (RMF)
- Support to Production Sites (US and EU-based)
- Prepare Biological Risk Assessments (BRA) in the frame of process changes on Legacy devices (incl. equipment, raw material, supplier changes etc.)
- Management of preclinical biocompatibility studies
- Planning, organization, monitoring and review of GLP biocompatibility (chemical and/or biological tests) studies with external laboratories
- Ensure compliance with Regulatory standards/guidelines
- Prepare Standard gap analyses and assess the impact(s) on current biocompatibility dossiers, studies and/or documentation
Skills & Experience Required:
- Bachelor's degree in relevant field
- 3+ years of biocompatibility of Medical Devices experience
- Knowledgeable about the biological evaluation standards, such as the ISO 10993 series
- Fluency in English
- French or German is a plus
- Knowledge of Microsoft Office Suite including Excel, Word, PowerPoint, Teams and SharePoint