Quality Specialist

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

The Quality Specialist serves as the company’s dedicated SFDA post-market vigilance officer, responsible for the

day-to-day operation of the post-market surveillance and vigilance system for medical devices distributed in the

Kingdom. The role ensures that complaints, adverse events, recalls and Field Safety Corrective Actions are captured, investigated and reported to the SFDA within regulatory timelines, and acts as a first-line focal point with the Authority. As a secondary responsibility, the role supports the Quality Manager in maintaining the ISO13485:2016 Quality Management System, including documentation, CAPA, audits and general quality activities.

2. ROLE AND RESPONSIBILITIES:

1 - Act as the dedicated focal point for SFDA post-market surveillance (PMS) and vigilance activities for all distributed medical devices.

2 - Receive, log, triage and investigate customer complaints and reported incidents, coordinating with principals /manufacturers and internal departments.

3- Assess reportability of adverse events and submit reports to SFDA through the NCMDR channels within the required timelines, maintaining a complete and auditable vigilance file.

Coordinate and execute recalls and Field Safety Corrective Actions (FSCA): distribute Field Safety Notices (FSN), track affected stock, perform quantity reconciliation and effectiveness checks, and prepare closure reports.

4- Monitor manufacturer safety communications, FSNs and regulatory alerts, and initiate the corresponding internal actions.

5- Maintain complaint and vigilance trending data, and escalates signals and repeated issues to the Quality Manager for CAPA and risk review.

6- Support the handling of expired, damaged and non-conforming products in line with internal SOPs and SFDA requirements.

7- Prepare periodic vigilance and post-market surveillance reports and maintain records ready for SFDA inspection.

B. QUALITY MANAGEMENT SYSTEM SUPPORT (SECONDARY ROLE)

1- Support the Quality Manager in maintaining the ISO 13485:2016 QMS, including control of documented information

(SOPs, forms, records) under the QA-SOP-XXX framework.

2- Assist in raising, tracking and closing CAPAs and nonconformities, and in preparing data for Management Review.

3 - Participate in internal and supplier audits as auditor or auditee support, and help follow up audit findings to closure.

4 - Support supplier quality tasks, incoming inspection records, and storage / warehouse quality checks (temperature,

5 - Contribute to customer satisfaction monitoring and internal quality-improvement initiatives.

6 - Provide general support to the Quality Manager on quality, compliance and regulatory tasks as assigned.

3. QUALIFICATIONS AND EDUCATION REQUIREMENTS:

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 with the operation of a QMS.

Preferred Certifications & Training

ISO 13485:2016 awareness or internal auditor training (preferred).

Complaint handling, CAPA or root-cause analysis training (advantage).

4. Required Knowledge of SFDA Regulations:

• PMS & Vigilance Post-market surveillance and adverse event reporting requirements, timelines and NCMDR reporting
• channels.
• Recalls & FSCA Field Safety Corrective Actions, Field Safety Notices and recall execution and reconciliation.
• MDMA Awareness of Medical Device Marketing Authorization and product listing status as it relates to distributed
• devices.
• MDS-G General awareness of relevant SFDA guidance documents and Good Distribution / Storage Practice

5. SKILLS AND COMPETENCIES:

• Strong attention to detail, record-keeping discipline and ability to meet strict reporting deadlines.
• Good investigation, documentation and communication skills.
• Proficiency in Arabic and English for SFDA correspondence and reporting.
• Ability to coordinate across departments (Warehouse, Commercial, Regulatory) and with external principals.
• Proficiency in MS Office and comfort with electronic reporting portals.
• Integrity, discretion and a patient-safety mindset.

6. Key Working Relationships:

• Internal Quality Manager, Regulatory Affairs, Warehouse & Logistics, Commercial / Sales, Customer Service.