Post-Market Vigilance Quality Lead

aljeel Medical; Riyadh; On-site; SAR 180,000 - 240,000; Full time

Job summary

aljeel Medical is seeking a Quality Specialist to serve as the SFDA PMS and vigilance focal point for all distributed medical devices in the Kingdom. The role ensures timely investigation and reporting of complaints, adverse events, recalls, and FSCA, acting as the primary liaison with SFDA and supporting the ISO 13485:2016 QMS.

You will maintain vigilance data, manage CAPA processes, and assist in internal audits and regulatory tasks, ensuring compliance with SFDA and company SOPs.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Pharmacy, Life Sciences, Medical Technology, Nursing, or a related scientific/health discipline.
• Minimum 2 years of experience in quality, regulatory affairs, vigilance within the medical device or healthcare sector.
• Familiarity with SFDA medical device requirements and QMS operation.

Responsibilities

• Act as the dedicated focal point for SFDA PMS and vigilance for all distributed medical devices.
• Receive, log, triage and investigate customer complaints and incidents, coordinating with principals and internal teams.
• Assess reportability of adverse events and submit reports to SFDA through NCMDR channels within regulatory timelines.
• Coordinate recalls and FSCA, distribute FSNs, track stock, reconcile quantities and prepare closure reports.
• Monitor manufacturer safety communications and regulatory alerts, initiating internal actions.
• Maintain vigilance data and escalate signals to the Quality Manager for CAPA and risk review.
• Prepare periodic vigilance and post-market surveillance reports and keep records for SFDA inspection.

Skills

Attention to detail

Investigation & documentation

Cross-functional coordination

MS Office proficiency

Arabic & English communication

Education

Bachelor’s degree in Biomedical Engineering/Pharmacy/Life Sciences/Medical Technology/Nursing or related

Tools

SFDA reporting portals

QMS documentation

Job description

aljeel Medical is seeking a Quality Specialist to serve as the SFDA PMS and vigilance focal point for all distributed medical devices in the Kingdom. The role ensures timely investigation and reporting of complaints, adverse events, recalls, and FSCA, acting as the primary liaison with SFDA and supporting the ISO 13485:2016 QMS.

You will maintain vigilance data, manage CAPA processes, and assist in internal audits and regulatory tasks, ensuring compliance with SFDA and company SOPs.