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.