Biological Safety Expert for Medical Devices
2 weeks ago
Job Title: Biocompatibility/Toxicology Expert
Overview of the Position: We are seeking a highly skilled Biocompatibility/Toxicology Expert to join our team at The Accuro Group. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the safety and performance of our medical devices.
Estimated Salary Range: $140,000 - $180,000 per year
Duties and Responsibilities:
- Study Design: Design and oversee studies to evaluate the safety and performance of medical devices.
- Biological Evaluation Plan/Report Preparation: Develop and maintain biological evaluation plans and reports for medical devices.
- Risk Management File (RMF) Review: Participate in the review and update of the Risk Management File (RMF).
- Cross-Collaboration: Collaborate with Regulatory Affairs, Clinical teams, and Production sites to ensure compliance with regulatory standards.
Requirements:
- Bachelor's Degree: A bachelor's degree in a relevant field such as biology, chemistry, or toxicology.
- Experience: 3+ years of experience in biocompatibility of medical devices.
- Language Skills: Fluency in English. French or German is a plus.
Location: Raleigh, NC 27615
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