Biocompatibility / Toxicology Expert - Professional Partners Group

Monday to Friday, from 8:00 to 5:00, Mondays and Fridays remote

The Biocompatibility / Toxicology Expert will support the Biocompatibility Team to ensure the evaluation of biological safety and performance of the company's Class III Absorbable Medical Devices for Aesthetics purpose (Dermal Fillers). She/he 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.

Major Duties & Description
1 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.

2 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)

3 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.)

4 Management of preclinical biocompatibility studies

Planning, organization, monitoring and review of GLP biocompatibility (chemical and/or biological tests) studies with external laboratories

5 Ensure compliance with Regulatory standards/guidelines

Prepare Standard gap analyses and assess the impact(s) on current biocompatibility dossiers, studies and/or documentation

Technical & Functional Skills
• Expertise in biocompatibility of Medical Devices
• 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
• Accurate, rigorous and clear communication (oral, written, face to face)
• Very good scientific and analytical approach
• Organized approach and able to work on multiple topics, with tight deadlines
• Team Player, but able to work in autonomy

Minimum Qualifications
• High scientific education such as biologist, biochemist, chemist (minimum BSc)
• Biocompatibility Expert (former experience in biocompatibility assessment of medical devices > 12 months)
• Medical Devices experience (> 3 years)

Physical Requirements

This position requires you to sit, stand and perform general office functions. You may also be required to lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.