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Biological Evaluation Specialist for Medical Devices
2 months ago
About the Role
Biological Evaluation Specialist – Join GN Store Nord A/S as we seek a skilled professional to lead our biological evaluation efforts for medical devices. In this role, you will be responsible for ensuring the highest quality and safety standards for our products.
Key Responsibilities
- Develop and implement biological evaluation plans for our medical devices.
- Compile and analyze data on materials, processes, and degradation over the lifecycle of our products.
- Perform biological risk assessments of materials and processes to ensure compliance with regulatory requirements.
- Coordinate with external testing labs to obtain biocompatibility studies and toxicological risk assessments.
- Prepare comprehensive biological evaluation reports for submission to regulatory authorities.
Requirements
- Bachelor's degree or higher in a relevant field, such as science, biology, chemistry, or engineering.
- Proven experience in biological evaluation, toxicology, or a related field.
- Excellent communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders.
- Fluency in English, with the ability to read, write, and communicate complex technical information.
About GN Store Nord A/S
At GN Store Nord A/S, we are dedicated to delivering innovative solutions that enhance the human experience. As a leader in the hearing, audio, and gaming industries, we strive to create products that bring people closer together. Our company culture values inclusivity, diversity, and innovation, and we are committed to creating a workplace that reflects these values.