Saif Alchalabi

• Review medical complaints and potentially reportable events for the purpose of researching and gathering additional information needed to determine MDR and/or Vigilance reportability.
• Interact with cross functional teams (e.g. Customer Service, Complaint Evaluations Group, and
• Complaint Investigations Group) to gather appropriate information to determine whether a complaint requires an MDR and/or Vigilance report and/or submit an MDR/Vigilance follow up report.
• Document-filing decision rationale in the Complaint Handling System.
• Filing of all medical events and reportable malfunctions within the required timeframe.
• Provide feedback and recommend solutions within the Quality team to promote accurate documentation of the complaint case.
• Assist in maintaining the Malfunction Reportability Assessment Matrix (MRAM), including updates to the Reportable Confirmed Malfunction List (RCML).
• Perform verification of MDRs/Vigilance reports, including support of data compiled for metrics, risk evaluations and various other activities.
• Assure compliance to the division's Medical Event and Quality System procedures ,and Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis
• Reviewed regulatory submissions to ensure compliance with industry standards.

• Managed communication between team members and external stakeholders effectively.
• Organized training sessions and workshops for staff development and skill enhancement.
• Developed documentation and reports to streamline operational processes and procedures.
• Implemented tracking systems to monitor project progress and deadlines consistently.
• Managed day-to-day operations of the department, including scheduling tasks, and assigning duties.
• Recommended solutions related to staffing issues and proposed procedural changes to managers.
• Assessing global regulations to maintain healthy compliance metrics.
• Facilitated collaboration between departments to enhance workflow efficiency.

.Track reportable cases and report to regulatory authorities, ethics committees, institutional review board , investigator.

. Perform quality control of safety data.

. Attend project team meetings and provide feedback to the line manager on any challenges.

. Read and acknowledge all necessary SOP and customer SOP as required.

. Identify and record quality issues and escalate to regulatory reporting.

• Recording and reporting adverse reactions obtained from healthcare professionals and consumers.
• Minimizing the risk of serious side effects.
• Adhered to good clinical practices, operating procedures and regulatory requirements.
• Developed quality control procedures for safety data.

Medical Device consulting company focusing on gaining information on US Quality System Regulations (CFR Title 21 820)
• Strengthened guidance on the creation and maintenance of quality system requirements for Device Master Record (DMR), Design History Record (DHR), and Design History File (DHF).

• Trained pharmacy interns and newly hired technicians.
• Assessed safety procedures and federal regulations to maintain pharmacy compliance.
• Supervised team of pharmacy technicians, interns and support staff.
• Dispensed medications after reviewing and interpreting prescriptions from healthcare providers.