Medical Devices Vigilance Specialist

Job Summary:

The Medical Devices Vigilance Specialist is accountable for ensuring that all safety and regulatory activities related to the medical devices registered in Egypt are managed in compliance with local Medical devices regulations and company policies/procedures at a local, regional, and global level and in accordance with any agreements with third party business partners.

The Medical Devices Vigilance Specialist will act as the contact point nominated to the Medical Devices Safety department in the Health Authorities as required by national regulation.

Key Duties and Responsibilities:

MEDICAL DEVICE LOCAL SYSTEM / REGULATIONS

• Actively collect local medical devices intelligence and communicate changes in local regulations to the regional Product Surveillance team.
• Ensure that the local medical devices vigilance System is established and is in accordance with the local medical Devices regulations in Egypt.
• Ensure Standard Operating Procedures (SOPs) and Work Instructions (WIs) are in place that comply with local regulatory requirements and align with global and international procedures.
• Draft the local SOPs / WIs with regional product surveillance team when required by the local regulations.
• Ensure that the Safety actions (Field Safety Notices; FSNs), (Field Safety Corrective actions; FSCAs) and recalls are communicated to the HA as per the local regulations and assist in implementations of actions if required.
• Act as the main contact point during local audits and inspections, managing communications and audit reports.

VIGILANCE REGULATORY REQUIREMENTS: (whenever required based on classifications and local regulations)

• Collaborate with the Head of local regulatory affairs and with the MDSD in the HA to understand the vigilance documents required to be submitted in various regulatory activities for the medical devices registered in Egypt.
• Communicate the proper requirements to the global team to ensure timely submission of the required documents to the HA.
• Assist in planning, drafting, revision and submission of the MD vigilance documents required for regulatory activities.
• Review the documents as per the local MD regulations and follow up with the global team for final authorizations and signatures.
• Compile the vigilance documents and handle the submissions to the Medical Devices safety department in the HA ensuring timeline, accuracy, comprehensiveness, and compliance with the local requirements.
• Follow up with the MDSD final approvals of the submitted vigilance documents.
• Escalate any comments received from the MDSD to the global team in a timely manner to ensure proper submissions on timeline.
• Follow up with the global team and the HA till submitting the required vigilance documents and notify the regulatory affairs manager on the approvals of submissions.

Medical Operations: Key responsibilities (40%)

1. Planning & Logistics

• Manage event approvals on system and logistics including venue selection, agenda scheduling, PO submission, AV requirements, travel arrangements, and accommodation for speakers and attendees.
• Coordinate with vendors, agencies, and external suppliers to execute event components smoothly.
• Ensure events comply with internal company policies and local regulations.

2. HCP & Speaker Management

• Prepare and track speaker contracts, invitations, and required documentation.
• Maintain accurate lists of participants and follow up on attendance.

4. Scientific Materials approvals

• Ensure all materials undergo medical and regulatory review before use.
• Prepare post-event evaluations, documentation, and insights.

5. Budgeting & Documentation

• Prepare event budgets, manage invoices, and track expenses to ensure cost control.
• Maintain accurate documentation required for audits, including agendas, attendee lists, contracts, and post-event reports.
• Handle payments and reconcile financials with procurement and finance.

6. On-Site Event Support

• Oversee setup and execution of the event on-site, including registration, troubleshooting, and coordination with the medical team.
• Ensure smooth flow of sessions and attendee engagement.

Sample Room Key responsibilities

• Receive, log, and track all samples arriving at or departing from the sample room.
• Inspect samples received to ensure their compliance with the relabeling requirements
• Organize and store samples in accordance with AbbVie's policies, safety, and labeling requirements.
• Maintain accurate and up-to-date inventory records of all samples and related documentation.
• Coordinate the distribution of samples to appropriate personnel
• Ensure samples are properly handled, preserved, and stored to prevent contamination or damage.
• Monitor environmental conditions in the sample room (temperature) and ensure compliance with company and regulatory requirements.
• Assist with periodic audits and inspections of sample inventory and storage practices.
• Maintain a clean, organized, and safe sample room environment.
• Report discrepancies, damaged samples, or procedural issues to management promptly.
• Participate in process improvements related to sample management and documentation.