What Jobs are available for Biomedical Engineer in Saudi Arabia?

‏
Job Responsibilities:

Install, inspect, and maintain medical equipment.

Coordinate with suppliers and follow up on technical support processes.

Prepare maintenance reports and ensure compliance with quality and safety standards.

Requirements:

Bachelor's degree in
Biomedical Engineering
or a related field.

Saudi nationality
is required.

Valid professional classification
from the Saudi Council of Engineers.

Previous experience in the field of medical devices.

Ability to troubleshoot equipment issues and prepare technical reports.

Job Summary:

Providing technical support and helping our customers by responding to their requests for service in a timely and efficient manner. Maintain professional reporting mechanism insuring medical equipment up time and customer satisfaction. Delivering high quality corrective maintenance, periodic preventative maintenance, and medical equipment installations.

Duties and Responsibilities

Key Responsibilities:

1. Installation: Expertly install and configure laboratory instruments, with a focus on CDG instruments, to meet the technical specifications and requirements of the laboratory.
2. Maintenance: Perform routine maintenance tasks, including calibration and adjustments, to uphold the reliability and accuracy of laboratory instruments.
3. Troubleshooting: Identify, diagnose, and resolve technical issues efficiently to minimize downtime and maintain uninterrupted functionality of CDG instruments.
4. Preventive Maintenance: Implement proactive measures to prevent potential issues, contributing to the overall longevity and performance of laboratory equipment.
5. Collaboration: Collaborate with laboratory staff to understand their needs, provide technical support, and offer training on proper instrument usage.
6. Documentation: Maintain detailed records of installation procedures, maintenance activities, and troubleshooting processes for compliance and continuous improvement.
7. Technology Integration: Stay abreast of the latest advancements in laboratory instrumentation, providing insights into potential upgrades or enhancements.

Qualifications:

1. Proven experience in the installation, maintenance, and troubleshooting of laboratory instruments, with a focus on CDG instruments.
2. Strong analytical and problem-solving skills.
3. Excellent communication and interpersonal skills for effective collaboration with laboratory personnel.
4. Adaptability to evolving technologies and ability to thrive in a dynamic laboratory environment.

Attributes:

1. Detail-oriented with a commitment to maintaining instrument accuracy.
2. Adaptable to changing priorities, able to work efficiently under pressure.
3. Dedication to ensuring the reliability and functionality of laboratory instruments.
4. Ability to work independently and adapt to different laboratory environments.

EXPERIENCE, Skills & Knowledge.

• Bachelor's degree in biomedical engineering or any related field.
• Saudi Council of Engineers

Experience

• A minimum of 1 years' experience in related field
• Laboratory equipment experience is a plus and preferable.
• Basic network knowledge is a plus

Languages

• Proficiency in English

Competencies

• Coaching skills.
• Communication skills.
• Public relations.
• Team player.
• Data Reporting.
• Product knowledge.
• Computer skills.
• Quality of work.
• Customer service.
• Agility.

The Maintenance Engineer - Biomedical is responsible for ensuring the safe, effective, and reliable maintenance of biomedical and clinical equipment, as well as supporting broader facilities maintenance operations across KAUST's community infrastructure. This role focuses on auditing, monitoring, and verifying the work of service providers, ensuring full compliance with technical, contractual, and safety standards.

The engineer will manage both preventive and corrective maintenance activities and contribute to long-term asset lifecycle management. The position requires technical expertise in biomedical systems, asset performance evaluation, compliance with international and local standards, and effective use of CMMS tools (SAP/Maximo).

• Ensure effective and safe execution of preventive, corrective, and predictive maintenance for biomedical and facility assets.
• Monitor maintenance activities to ensure alignment with KAUST standards, safety protocols, SOPs, and KPIs.
• Conduct audits, inspections, and technical reviews to verify service quality and compliance with regulatory standards (JCI, SFDA, CBAHI/SBAHI, IEC, HTM).
• Support troubleshooting, root cause analysis, and the implementation of corrective and preventive actions.
• Oversee calibration, maintenance, and performance verification of biomedical equipment in the community medical facility.
• Maintain accurate asset data in the CMMS (SAP/Maximo) and support lifecycle planning and preventive maintenance strategies.
• Coordinate with stakeholders and provide regular reports and recommendations to improve service quality and asset reliability.
• Demonstrate expertise in biomedical equipment calibration, testing, performance verification, and lifecycle management.

Requirements

• Bachelor's degree in Biomedical Engineering or related engineering discipline.
• Minimum 4-6 years of experience in the maintenance and operation of biomedical systems and general facilities equipment.
• Advanced knowledge of preventive, corrective, and predictive maintenance methodologies.
• Strong understanding of biomedical equipment standards, device safety, and infection control protocols.
• Proficiency in Computerized Maintenance Management Systems (CMMS), preferably SAP or Maximo.
• Strong technical expertise in biomedical equipment calibration, testing, and lifecycle management.
• In-depth understanding of international codes and standards related to facilities and medical equipment.
• Proven track record in contractor management, inspections, audits, and performance monitoring.
• Hands-on experience in complying with international and local regulations and standards, including: JCI, CBAHI/SBAHI, SFDA, IEC 60601, HTM
• Certified Maintenance & Reliability Professional (CMRP) - Preferred
• Biomedical Equipment Technician (BMET) certification - Preferred

Job Title:
Medical Devices & Disposables Sales

Location:
Riyadh, Saudi Arabia

Company:
Supplora

Job Summary

Supplora is seeking an experienced
Medical Devices & Disposables Sales Professional
with a strong background in the medical supplies and devices industry. The ideal candidate will bring over 8 years of proven success in sales and procurement, with a deep understanding of the Saudi healthcare market and a solid network of contacts across hospitals, clinics.

This is a high-impact, results-driven role suitable for a professional who thrives in a fast-paced, startup environment and can confidently drive business growth through strategic sales initiatives and supply chain management.

Key Responsibilities

• Develop and implement effective sales strategies to achieve company revenue targets and expand market share.
• Identify and pursue new business opportunities with hospitals, clinics, and medical centers across Saudi Arabia.
• Manage the full purchasing lifecycle, from vendor selection to price negotiation and product delivery.
• Build and nurture long-term relationships with key stakeholders, including healthcare professionals and procurement departments.
• Conduct on-site client visits, deliver compelling product presentations, and lead contract negotiations.
• Collaborate with internal teams to align purchasing and sales operations for optimal efficiency.
• Stay up to date with industry trends, market developments, competitor activity, and SFDA regulatory requirements.
• Prepare and present regular sales performance reports, market forecasts, and procurement analysis.

Requirements

• Bachelor's degree in Business Administration, Marketing, Biomedical Sciences, or a related field.
• Minimum of
  8 years of experience
  in medical devices and disposables sales and purchasing.
• Established network and strong relationships with hospitals, clinics, and healthcare procurement teams in Saudi Arabia.
• In-depth knowledge of
  Saudi healthcare regulations
  and
  SFDA product registration processes
  .
• Excellent communication, negotiation, and presentation skills.
• Proven track record of meeting or exceeding sales targets and effectively managing procurement activities.
• Fluent in
  English
  ; proficiency in
  Arabic
  is highly preferred.
• Ability to work independently and thrive in a dynamic, fast-growing startup environment.

Job Summary:

We are seeking a proactive and results-driven Regulatory Affairs Specialist to join our Regulatory Affairs office – Medical Devices & IVD. The role centers on leading SFDA market access end-to-end and partnering cross-functionally to enable on-time launches. Key responsibilities include device classification (A–D), MDMA dossier preparation and submission, securing approvals, maintaining post-market compliance (UDI/Saudi-DI, vigilance, renewals), sustaining establishment licenses, and driving regulatory intelligence, timeline control, and risk management.

Key Responsibilities:

1- Regulatory strategy & planning: Define Saudi registration pathways, scope, and timelines per device/IVD risk class; create submission Gantt, critical path, and RFT (right-first-time) targets.

2- Device classification: Determine KSA class (A–D) per SFDA classification rules; document rationale and evidence for audits.

3- MDMA submissions: Lead full Technical File (TFA) builds per SFDA MDS-REQ 1 (Essential Principles, ISO 14971 risk, clinical evaluation/PMS/PMCF, bench testing, software/EMC/biocomp/sterility as applicable). Manage Q&A with SFDA and close queries on time.

4- GHAD e-services ownership: Create/maintain accounts, submit/track applications, handle fee payments, and manage renewals/updates (change control).

5- Authorized Representative (AR) & licensing: Coordinate/maintain AR agreements for overseas manufacturers; ensure our importer/distributor/manufacturer licenses remain valid and compliant.

6- Labeling & IFU compliance: Enforce SFDA labeling (incl. Arabic), UDI carrier placement, and traceability readiness across SKUs and packaging tiers.

7- UDI (Saudi-DI): Register and maintain device identifiers and metadata; monitor rollout deadlines and ensure 100% coverage before shipments.

8- Post-market surveillance: Run vigilance, FSCAs, and trend reporting; maintain PMS plans/PSURs; drive CAPA with QA/Service.

9- Stakeholder orchestration: Work with Commercial, Service, Supply Chain, QA, and OEM partners to unblock submissions, supply, and launches.

10- Regulatory intelligence: Track SFDA updates, guidance revisions, and fee/timeline changes; brief leadership with impact/risk/mitigations.

Minimum Qualifications:

1- Bachelor's degree in Biomedical Engineering, Pharmacy, Medical Laboratory Sciences, Regulatory Affairs, or a related life-science/engineering field.

2- Experience: 3–5 years hands-on RA for medical devices/IVDs in Saudi Arabia, with proven MDMA approvals (Class B–D and/or IVDs preferred).

3- Languages: Arabic and English - proficiency (required).

Technical Competencies:

1- Solid command of SFDA MDMA process and dossier structure (administrative + technical; EP checklist; CER; PMS/PMCF).

2- Working knowledge of ISO 13485 QMS and ISO 14971 risk; familiarity with IEC 60601, IEC 62304, IEC , and relevant IVD standards (as applicable).

3- Fluency with GHAD portal operations (account setup, submissions, updates, renewals).

4- Demonstrated device classification rationale per SFDA rules (A–D) and bundling logic when applicable.

5- UDI (Saudi-DI) data stewardship: DI creation, data fields, and label carriers across packaging levels.

6- Evidence of leading vigilance/FSCA and audit responses with zero critical findings.

Core Skills:

1- Owner mindset, bias for action, and the ability to ship compliant submissions quickly.

2- Analytical writing, structured problem-solving, and meticulous documentation.

3- Cross-functional influence (Commercial, QA/RA, Service, Supply Chain, OEMs).

4- Project management: timeline control, dependency mapping, and risk registers.

5- Clear, concise communication in Arabic and English.

KPIs You'll Own:

1- Approval lead time (submission → MDMA certificate).

2- Right-first-time rate (zero major deficiencies).

3- Renewal/Update on-time rate (≤0 lapses).

4- UDI coverage (% SKUs registered in Saudi-DI).

5- Audit performance (findings severity and closure time).

Nice-to-Have:

1- Prior experience with AR management and multi-OEM portfolios.

2- Exposure to AI/Software as a Medical Device (SaMD) and digital diagnostics.

3- Experience supporting tenders/imports (MDIL exemptions for demos/training where applicable).

4- Regulatory Basis We Follow (SFDA)

5- MDMA is the unified route for devices/IVDs in KSA

6- Technical and clinical requirements per MDS-REQ 1 (Essential Principles, risk, CER, PMS/PMCF, etc.).

7- Risk classification A–D and IVD rules per MDS-G008.

8- UDI (Saudi-DI) data submission and maintenance requirements.

9- Licensing of medical device establishments (importer/distributor/AR/manufacturer).

10- GHAD portal for account creation and electronic submissions.

How to Apply:

Via
LinkedIn
or
send your CV
(English) and a one-page case snapshot of an SFDA submission you led to , with the subject: Regulatory Affairs Specialist – Medical Devices (Riyadh).

Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.

The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.

Key Accountabilities

• Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.
• Manage communication with SFDA authorities for product approvals and renewals.
• Track and interpret new regulations impacting medical device compliance.
• Maintain product registration database and ensure documentation accuracy.
• Collaborate with QA, R&D, and Production to ensure regulatory alignment.

Knowledge, Skills, And Experience

• Bachelor's degree in Pharmacy, Biomedical Engineering, or Science.
• 8+ years of experience in Regulatory Affairs for medical devices.
• Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.
• Strong documentation and submission management skills.
• Excellent English communication.

Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.

The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.

• Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.
• Manage communication with SFDA authorities for product approvals and renewals.
• Track and interpret new regulations impacting medical device compliance.
• Maintain product registration database and ensure documentation accuracy.
• Collaborate with QA, R&D, and Production to ensure regulatory alignment.

• Bachelor's degree in Pharmacy, Biomedical Engineering, or Science.
• 8+ years of experience in Regulatory Affairs for medical devices.
• Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.
• Strong documentation and submission management skills.
• Excellent English communication.

Main Purpose of Job

Establish and maintain control over the QMS and BCM to ensure that all medical devices distribution, storage, and logistics operations comply with Saudi regulatory authorities, SFDA requirements, and international standards.

Functional Responsibilities

• Establish, maintain, and continually improve the Quality Management System (QMS) and Business Continuity Management (BCM) to ensure full compliance with SFDA and international standards (e.g., ISO 13485, 9001, 45001,

• Develop and control quality-related policies, SOPs, and procedures across all operations (procurement, warehousing, sales, and distribution).

• Ensure regulatory compliance of all facilities and logistics operations with SFDA and relevant authorities.

• Lead external audits (SFDA, licensors) and manage internal audit programs, ensuring timely CAPA implementation.

• Oversee risk management (QRM) and business continuity (BCP/BCM) processes for all distribution activities.

• Monitor quality KPIs and drive continuous improvement initiatives to enhance operational excellence.

• Supervise warehouse quality operations, ensuring adherence to Good Storage Practices (GSP), environmental control, and proper product disposition.

• Manage training programs on GMP/GDP/GSP and ensure technical competency of sales, logistics, and clinical teams.

• Handle customer complaints, post-market surveillance, and regulatory reporting (MDR/adverse events) to SFDA.

• Oversee supplier qualification and audits to ensure compliance with medical device quality standards.

• Support ESG and HSE initiatives, ensuring safe waste management and sustainability compliance.

Job Requirements

Qualifications

• Bachelor's degree in Engineering, Science or Regulatory Affairs.

Experience

• Minimum 3 years in related field of Operations

Language

• Required English - proficient.
• Preferred Arabic - proficient.

Leverage your abilities and join a leading company specializing in medical device manufacturing in Saudi Arabia.

The Head of Quality Assurance will lead and oversee all quality operations to ensure products meet the highest standards of safety, performance, and compliance with SFDA and ISO 13485 requirements.

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with SFDA and international standards.
• Lead internal and external audits, manage CAPA activities, and ensure continual improvement.
• Monitor and evaluate quality KPIs and performance metrics across all production lines.
• Oversee process validation, supplier qualification, and document control.
• Collaborate with production and R&D to maintain consistent product quality.
• Promote a strong culture of quality awareness and regulatory compliance across departments.
• Ensure staff training, documentation accuracy, and audit readiness at all times.

• Bachelor's degree in Pharmacy, Biomedical Engineering, or Life Sciences (Master's preferred).
• Minimum 10+ years of experience in Quality Assurance within the medical device industry.
• Deep understanding of SFDA requirements, ISO 13485, and GMP standards.
• Strong leadership and analytical skills with proven experience in audit management.
• Excellent command of English; Arabic proficiency is an advantage.