25 Medical Affairs 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.

Job Purpose / Summary
Responsible for staffing and managing Employee, Consultant or Freelance Clinical Research Associates (CRAs), In-House Clinical Research Associates (, Clinical Project Assistants (CPAs) and Clinical Projects Coordinators (CPCs) and ensuring adherence to and implementation of CTI policies. Manage quality and consistency of CRA services across multiple projects according to all applicable regulatory guidelines, Good Clinical Practices (GCPs) and Standard Operating Procedures (SOPs).

Essential Functions

• Responsible for the ongoing job specific training and mentoring of the subordinate CRAs and CPAs/CPCs s in accordance with Department goals and mission.  Supervision of the work of subordinate CRAs and CPAs/CPCs.
• First line of communication and escalation for the subordinate CRAs and CPAs/CPCs, including for HR and administrative issues.
• Issue, Task and Time management of the subordinate CRAs and CPAs/CPCs.
• Assuring compliance of subordinate CRAs and CPAs/CPCs to the applicable procedures, guidelines, timelines, and deliverables.
• Regular assessments and appraisals of CRAs and CPAs/CPCs and their level of competence.
• Quality Control - performs co-monitoring visits and reviews visit reports for the subordinate CRAs when needed.
• Regular reporting to Director CLO Dept. and participation in meetings with other CRMs, PMs.  Participate in the process of development and update of department-specific company SOPs and Wis when required
• Execute any activities in compliance with applicable SOPs, instructions and principles.
• Provide enough/trained resources for all projects to ensure smooth conduction of study specific activities.
• Collaborate with Director of clinical operations , on planning, assigning, and directing billable work assignments to CRAs, to ensure projects are properly resourced and study timelines are met.
• Assist in collecting preliminary and follow-up information from clients, with the purpose of identifying and evaluating project feasibility pertaining to clinical monitoring.
• Assist with defining operational Key Performance Indicators and departmental goals.
• Manage recruitment process for CRAs (and Consultant/Freelance CRAs as applicable), including review of CVs and conducting interviews collaboratively with Human Resources and others.
• Collaborate with other functional areas within CTI to ensure CRA (and Consultant/Freelance CRA as applicable) on-boarding, off-boarding, and project handovers are effective and timely

What You'll Bring:

• 2-3 years clinical research monitoring experience
• Practical experience in conducting clinical studies with pharmaceutical company or Contract Research Organization (CRO)
• Bachelor's degree in allied health fields such as nursing, pharmacy, or health science or equivalent experience as determined by CTI Management and Human Resources

About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit

Why CTI?
At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.

• Advance Your Career - We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
• Join an Award-Winning and Valued Team - We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact - We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website
)
or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process

Company Description

ClinLia is a Saudi Clinical Research Organization (CRO) with extensive experience in clinical research support and management services. We operate across a broad range of therapeutic areas to align with the new vision of Saudi Arabia 2030. Our goal is to advance clinical research and innovations to position the Kingdom on the clinical trials map.

Role Description

This is a full-time, on-site role located in Riyadh for a Clinical Research Coordinator/Laboratory Qualified. The Coordinator will be responsible for overseeing day-to-day clinical research activities, obtaining informed consent from participants, ensuring adherence to protocols, and managing clinical trials. Additional duties include handling laboratory tasks, conducting research, and ensuring compliance with regulatory requirements.

Qualifications

• Experience with Informed Consent and Protocol adherence
• Background in Research and Clinical Research Experience
• Experience managing Clinical Trials
• Excellent organizational and communication skills
• Ability to work on-site in Riyadh
• Bachelor's degree in a related field (e.g., life sciences, healthcare)
• Previous experience in a laboratory setting is a plus

Clinical Research Associate (level dependent on experience)

Job Purpose/Summary

As a CRA you will be responsible for the successful conduct of clinical trials and serve as the main contact for the investigative site by representing CTI in a professional manner.

What You'll Do

• Conduct evaluation, initiation, monitoring and close out visits
• Assist with regulatory and study start-up activities including contract and budget negotiations
• Ensure clinical data integrity and meet study timelines
• Provide ongoing updates and support to project management
• Attend global project meetings including investigator meetings and global team teleconferences
• Complete assigned training programs in drug development processes, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements.

What You Bring

• 2 - 3 years of clinical research experience as a CRA or related profession
• Life science background
• Excellent knowledge in ICH-GCP and regulatory requirement
• Fluent in English

Why CTI?

At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.

For that reason, we treat our team members with the respect they deserve, and our numbers show it:

• We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
• We value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
• Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
• We think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
• We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
• Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

Are you interested? Then we look forward to your electronic application, with a tabular CV in English.

CTI Clinical Trial and Consulting Services

Filipa Magalhães

JOB PURPOSE / SUMMARY

Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while developing an understanding of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP) and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

ESSENTIAL FUNCTIONS

• Serve as main CTI contact for assigned study sites

• Conduct site visits (pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV)) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP

• Assist with study start-up activities, including feasibility, pre-study activities and site selection

• Collect, review and track essential/regulatory documents
• Participate in and complete all general and study specific training as required
• Participate in investigator, client and project team meetings
• Assist in developing patient enrollment strategies with Project Team and study sites
• Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
• Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
• Conduct remote monitoring and complete all the related activities in accordance with study specific Monitoring Plan
• Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
• Assist with project-specific activities as member of Project Team
• May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.
• May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures
• Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
• Provide regular updates to Sponsor/ Client
• Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments
• Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
• Identify site issues and implement corrective actions or escalate as appropriate
• Liaise with Clinical Data Management for data cleaning activities

What You'll Bring:

• At least 2 years of clinical nursing experience, or at least 1 year of experience in related health care or clinical research work experience (ONCOLOGY) (ie, Study Coordinator), or at least 1 year experience performing relevant project support in-house functions

• Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit

Why CTI?

At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.

• Advance Your Career - We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
• Join an Award-Winning and Valued Team - We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact - We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from  email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website
)
or from our verified LinkedIn page.

Please Note

• • We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process

Serve as main CTI contact for assigned study sites

• Conduct site visits (pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV)) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP

• Assist with study start-up activities, including feasibility, pre-study activities and site selection

• Collect, review and track essential/regulatory documents
• Participate in and complete all general and study specific training as required
• Participate in investigator, client and project team meetings
• Assist in developing patient enrollment strategies with Project Team and study sites
• Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
• Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
• Conduct remote monitoring and complete all the related activities in accordance with study specific Monitoring Plan
• Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
• Assist with project-specific activities as member of Project Team
• May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.
• May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures
• Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
• Provide regular updates to Sponsor/ Client
• Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments
• Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
• Identify site issues and implement corrective actions or escalate as appropriate
• Liaise with Clinical Data Management for data cleaning activities

• At least 2 years of clinical nursing experience, or at least 1 year of experience in related health care or clinical research work experience (ONCOLOGY) (ie, Study Coordinator), or at least 1 year experience performing relevant project support in-house functions

• Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources

Job Title: Senior Clinical Research Associate (CRA)

Location: Riyadh, KSA

Job Type: Full-time

Job Description

We are seeking a highly motivated Senior CRA to join our team on behalf of a leading multinational organization. The selected candidate will be responsible for overseeing and managing clinical trials from initiation to close-out, ensuring compliance with protocols, regulatory requirements, and SOPs.

Key Responsibilities:

• Oversee and coordinate clinical trial activities including investigator selection, patient recruitment analysis, and preparation of study-related documentation (protocols, CRFs, IBs, informed consents, agreements).
• Prepare and manage regulatory submissions and follow-up to ensure timely approvals.
• Organize and conduct investigator start-up meetings and site initiation visits.
• Ensure proper drug accountability at assigned clinical sites.
• Verify CRF data entries against source documentation.
• Ensure timely reporting and follow-up of all adverse events in accordance with protocol and applicable guidelines.
• Monitor trial activities in line with the protocol, monitoring plan, and SOPs.
• Plan, order, and manage clinical trial materials (CTMs) from sponsors.
• Maintain accurate and up-to-date Trial Master Files (TMFs) in compliance with local, legal, and ethical standards.
• Track completed CRFs and ensure timely transfer to data management.
• Maintain essential project files including EC approvals, CVs, IBs, protocols, consent forms, lab ranges, and correspondence.
• Deliver study-specific training to site staff and ensure effective ongoing communication.
• Escalate quality concerns to the Clinical Operations Manager (COM) and ensure corrective measures are implemented.
• Document site management activities, monitoring visit findings, and follow-up actions through detailed reports.
• Support patient recruitment strategies via investigator engagement, newsletters, and awareness initiatives.
• Collaborate closely with the COM and assume delegated responsibilities when required.
• Supervise and mentor CRAs and clinical trial assistants, providing guidance and training as needed.
• Report any instances of GCP non-compliance, misconduct, or fraud appropriately.
• Actively participate in departmental planning and contribute to continuous process improvement.

Qualifications:

• Education: Degree in Pharmacy or Medicine.
• Experience: Minimum of 2 years in clinical research.
• Residency: Based in Riyadh, KSA.

Job Type: Full-time