شركة المقاييس الحيوية تعلن عن وظيفة مساعد الشؤون التنظيمية في الرياض

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.