16 Biomedical Engineering jobs in Saudi Arabia

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.

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.

Location:
Riyadh – KSA

Company:
Nestlé Saudi Arabia

Full-time
Position Summary
Joining Nestlé means you are joining the largest Food and Beverage company in the world. At our very core, we are a human company driven by our purpose to improve the quality of life and contribute to a healthier future.

You will play a crucial role in driving the success of our company's feeding medical devices portfolio. Your primary responsibility will be to develop and maintain strong relationships with key accounts, including hospitals, healthcare facilities, and distributors, to maximize sales and market share.

A DAY IN THE LIFE …

• You will be responsible for identifying and targeting potential key accounts, understanding their unique needs and challenges, and presenting our feeding medical devices as the optimal solution.
• You will collaborate closely with the sales and marketing teams to develop and execute strategic account plans, ensuring alignment with overall business objectives.
• Your expertise in medical devices, particularly in the field of feeding, will be essential in providing technical support and training to key accounts.
• You will serve as a trusted advisor, offering product demonstrations, conducting educational sessions, and addressing any inquiries or concerns.
• Additionally, you will stay up-to-date with industry trends, competitor activities, and regulatory requirements to proactively identify opportunities and mitigate potential risks.
• To excel in this role, you must possess exceptional communication and negotiation skills, as you will be responsible for negotiating contracts and pricing agreements with key accounts. Your ability to build and maintain strong relationships, coupled with your persuasive and influential nature, will be instrumental in achieving sales targets and fostering long-term partnerships.

What Will Make You Successful…

• Bachelor's degree in a related field (e.g., Medical, healthcare, life sciences, business).
• Strong understanding of the healthcare industry, including hospital systems, procurement processes, and regulatory requirements.
• Ability to analyze market trends, identify opportunities, and develop strategic account plans.
• Proactive and results-oriented mindset, with a track record of meeting or exceeding sales targets.
• Willingness to travel as required to meet with key accounts and attend industry conferences or events.
• In-depth knowledge of feeding medical devices, including their applications, benefits, and usage is a plus.
• Excellent skills in Microsoft Office applications "PowerPoint, Word, and Excel".
• Excellent communication, presentation, and negotiation skills
• Full proficiency in both English and Arabic language skills.
• Valid driving license.

Join our team as an associate Manager, Key Account Specialist for Feeding Medical Devices and contribute to improving patient care by ensuring the availability and utilization of our cutting-edge feeding medical devices. Together, we can make a significant impact on the lives of patients and healthcare professionals alike.

Location: Riyadh – KSA

Company: Nestlé Saudi Arabia

Full-time

POSITION SUMMARY

Joining Nestlé means you are joining the largest Food and Beverage company in the world. At our very core, we are a human company driven by our purpose to improve the quality of life and contribute to a healthier future.

You will play a crucial role in driving the success of our company's feeding medical devices portfolio. Your primary responsibility will be to develop and maintain strong relationships with key accounts, including hospitals, healthcare facilities, and distributors, to maximize sales and market share.

A DAY IN THE LIFE …

• You will be responsible for identifying and targeting potential key accounts, understanding their unique needs and challenges, and presenting our feeding medical devices as the optimal solution.
• You will collaborate closely with the sales and marketing teams to develop and execute strategic account plans, ensuring alignment with overall business objectives.
• Your expertise in medical devices, particularly in the field of feeding, will be essential in providing technical support and training to key accounts.
• You will serve as a trusted advisor, offering product demonstrations, conducting educational sessions, and addressing any inquiries or concerns.
• Additionally, you will stay up-to-date with industry trends, competitor activities, and regulatory requirements to proactively identify opportunities and mitigate potential risks.
• To excel in this role, you must possess exceptional communication and negotiation skills, as you will be responsible for negotiating contracts and pricing agreements with key accounts. Your ability to build and maintain strong relationships, coupled with your persuasive and influential nature, will be instrumental in achieving sales targets and fostering long-term partnerships.

What will make you successful…

• Bachelor's degree in a related field (e.g., Medical, healthcare, life sciences, business).
• Strong understanding of the healthcare industry, including hospital systems, procurement processes, and regulatory requirements.
• Ability to analyze market trends, identify opportunities, and develop strategic account plans.
• Proactive and results-oriented mindset, with a track record of meeting or exceeding sales targets.
• Willingness to travel as required to meet with key accounts and attend industry conferences or events.
• In-depth knowledge of feeding medical devices, including their applications, benefits, and usage is a plus.
• Excellent skills in Microsoft Office applications "PowerPoint, Word, and Excel".
• Excellent communication, presentation, and negotiation skills
• Full proficiency in both English and Arabic language skills.
• Valid driving license.

Join our team as an associate Manager, Key Account Specialist for Feeding Medical Devices and contribute to improving patient care by ensuring the availability and utilization of our cutting-edge feeding medical devices. Together, we can make a significant impact on the lives of patients and healthcare professionals alike.

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.

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.