Description
The Regulatory Affairs Associate will be responsible for ensuring compliance with all relevant SFDA regulations for the registration and post-market surveillance of medical devices.
The responsibilities of the IVD Regulatory Affairs Associate include:
- Constant learning and developing knowledge of the SFDA regulations and identifying & interpreting relevant regulatory guidelines.
- Interpret regulatory rules or rule changes and ensure that they are communicated through company policies and procedures.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or document changes.
- Reviewing the initial documentation and ensuring its compliance with regulations.
- Corresponding with the client on the technical documentation.
- Submission of the relevant application to the SFDA for the relevant process and following up on the application status & addressing the SFDA inquiries.
- Contacting and visiting the SFDA when required.
- Following up with the client within 2-3 days.
- Attend meetings with the client when required.
- Keeping track of all the work done for the client and managing its information.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Maintain daily trackers.
- Compile and maintain regulatory documentation databases or systems.
- Support managers and colleagues.
- Report directly to the Head of IVD & Establishment Registration Department.
- Attend employee regulatory training.
- Understand, respect, and follow all company policies and procedures.
Required Skills and Experience:
- Bachelor’s degree in a related field (e.g., Medical Laboratory, Biochemistry).
- Good communication skills, both verbal and written in Arabic and English.
- Strong attention to detail.
- Knowledge of the Saudi and international healthcare market.