key responsibilities:
1. ensure compliance with medical devices regulations: as a biomedical trainee, you will be responsible for ensuring that all medical devices and equipment meet the necessary regulatory standards and guidelines.
2. assist in conducting clinical trials: you will support the team in planning and executing clinical trials to evaluate the effectiveness and safety of new medical devices.
3. manage ce certifications: you will help in obtaining and maintaining ce certifications for medical devices, ensuring they meet european regulatory requirements.
4. support fda submissions: assist in preparing and submitting documentation to the fda for approval of new medical devices or modifications to existing ones.
5. assist in patent applications: help in researching, drafting, and filing patent applications to protect the intellectual property of new medical devices.
6. assist in iso certifications: support in obtaining and maintaining iso certifications for quality management systems related to medical devices.
7. assist in devices calibration: help in calibrating medical devices to ensure accurate and reliable performance.
required skills and expectations:
- post graduate diploma or in biomedical engineering or related field.
- knowledge of medical devices compliances and regulations.
- strong attention to detail and ability to follow strict protocols.
- familiarity with ce certifications, fda regulations, patent processes, iso standards, and devices calibration.
- excellent communication and teamwork skills.
- ability to work under supervision and learn quickly in a fast-paced environment.