26 Financial Regulations jobs in Saudi Arabia

Date posted: Sep 10, 2025

City: Riyadh

Country/Region: SA

Type of Contract: Full-time Employment / Unlimited

Job Requisition ID: 9758

Regulatory Affairs Specialist - KSA

Job Purpose

• The Regulatory Affairs Specialist focuses on ensuring that the organization meets all of the applicable regulations. Their goal is to ensure that new products meet certain requirements as set by Health Authorities.
• Regulatory Affairs Specialist ME is responsible for Saudi Arabia activities (KSA).
• Identifying all elements and actions necessary for registering and maintaining valid marketing authorizations in KSA.
• Collaboration with the local partners, local authorities and WRA in France.
• Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations.
• Handle registrations of new products/sites/medical devices, pricing as well as maintaining life cycle of products in KSA, including renewals and variations.
• Ensure that all relevant regulations are fully met in dossiers, with the aim of complying with the requirements established by Health Authorities.
• Collaborates closely with the Department Head in all department related tasks and activities.
• Compile and prepare new products and manufacturing sites registration files for submissions to authorities in KSA as per Regulatory timelines.
• Cross functionality & collaboration with Global teams as well as all ME departments, provide regulatory support and guidance whenever required.

Role Responsibilities
Life-Cycle
management of products

• Pre-registration coordination with WRA and preparation of documentation for KSA to compile the product and manufacturing site files, Review/ Preparation/Submission of dossiers, fees, inquiries, answers to questions, approvals.
• Life-cycle management of products that includes new registrations, renewals/minor variation of both products and sites.
• Follow country specific procedures and SFDA guidelines in the KSA market.
• Coordination & liaising with WRA teams/distributors for preparation of all types of regulatory dossiers & local documentation.
• Preparation of price forms and related documentation for new product registration files.
• Liaising with WRA, agents and authorities for documentation submission and follow-up and keep track.
• To keep track of the registration status of products with submission, registration, expiry dates.

Regulatory Tasks

• Closely collaborate with the Head of the Department for all regulatory tasks.
• Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA.
• Involved actively in the budget preparation of KSA Regulatory Affairs.
• Follow-up on regulatory guidelines and ensure sharing of regulatory information with all concerned.
• Reference standard submissions to the authorities.
• Helping the Supply Chain Department for tenders - preparation of documentation for institutional tender submissions.
• Actively involved in Regulatory Audits.

Regulatory Site Management

• For all activities related to KSA -WRA Portal, Ereca, Solaris, LSRIMS, Cosac.

Other Related Tasks

• Management/Organizing department supported conferences for Health Authorities in the ME countries.
• Liaise closely with agent and Health Authorities in KSA.
• Responsible for Change Controls for Variations for the ME region.
• Work as a deputy for the local responsible person for advertisement/promotional material.
• Deputy Local Responsible person for validation of Packaging Items.
• Cross collaboration with other ME departments.

Dimensions

• Geographical span: ME - KSA.
• Work with the ME Regulatory Lead to develop a detailed understanding of regulatory guidelines and technical requirements in KSA.
• Life cycle management of products, understanding of industry-specific regulations, audit procedures, and the ability to ensure compliance with regulatory standards.
• Work and support the KSA Regulatory Affairs team.
• Cross-functionality with other departments.
• Report to the Head of the Department.

Requirements
Educational
qualifications

• Bachelor's Degree in Pharmacy / Science.

Relevant Experience

• 3+ years of relevant pharmaceutical regulatory experience within a large multinational organization.
• Experience working in Saudi Arabia (preferred).
• Experience of working within a Global pharmaceutical company would be an advantage.

Skills & Personal Characteristics

• Good knowledge of the Regulatory environment and procedures in KSA.
• Sharp Regulatory Intelligence.
• Ability to work cross functional to resolve complex issues.
• Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure, team player.
• Multi-tasking, organized, Process & Result oriented, Focused, Problem solving, good judgment and decision-making capability.
• Excellent interpersonal, Negotiation and relationship building skills.
• Excellent interpersonal, communication & digital skills.
• Written and spoken fluency in English & Arabic (French is an added advantage).

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit. All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

Date posted: Sep 10, 2025

City: Riyadh

Country/Region: SA

Type of Contract: Full-time Employment / Unlimited

Job Requisition ID: 9758

Regulatory Affairs Specialist - KSA

.

Job Purpose

• The Regulatory Affairs Specialist focuses on ensuring that the organization meets all of the applicable regulations. Their goal is to ensure that new products meet certain requirements as set by Health Authorities.
• Regulatory Affairs Specialist ME is responsible for Saudi Arabia activities (KSA).
• Identifying all elements and actions necessary for registering and maintaining valid marketing authorizations in KSA.
• Collaboration with the local partners, local authorities and WRA in France.
• Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations.
• Handle registrations of new products/sites/medical devices, pricing as well as maintaining life cycle of products in KSA, including renewals and variations.
• Ensure that all relevant regulations are fully met in dossiers, with the aim of complying with the requirements established by Health Authorities.
• Collaborates closely with the Department Head in all department related tasks and activities.
• Compile and prepare new products and manufacturing sites registration files for submissions to authorities in KSA as per Regulatory timelines.
• Cross functionality & collaboration with Global teams as well as all ME departments, provide regulatory support and guidance whenever required.

Role Responsibilities

Life-Cycle management of products

• Pre-registration coordination with WRA and preparation of documentation for KSA to compile the product and manufacturing site files, Review/ Preparation/Submission of dossiers, fees, inquiries, answers to questions, approvals.
• Life-cycle management of products that includes new registrations, renewals/minor variation of both products and sites.
• Follow country specific procedures and SFDA guidelines in the KSA market.
• Coordination & liaising with WRA teams/distributors for preparation of all types of regulatory dossiers & local documentation.
• Preparation of price forms and related documentation for new product registration files.
• Liaising with WRA, agents and authorities for documentation submission and follow-up and keep track.
• To keep track of the registration status of products with submission, registration, expiry dates.

Regulatory Tasks

• Closely collaborate with the Head of the Department for all regulatory tasks.
• Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA.
• Involved actively in the budget preparation of KSA Regulatory Affairs.
• Follow-up on regulatory guidelines and ensure sharing of regulatory information with all concerned.
• Reference standard submissions to the authorities.
• Helping the Supply Chain Department for tenders - preparation of documentation for institutional tender submissions.
• Actively involved in Regulatory Audits.

Regulatory Site Management

• For all activities related to KSA -WRA Portal, Ereca, Solaris, LSRIMS, Cosac.

Other related tasks

• Management/Organizing department supported conferences for Health Authorities in the ME countries.
• Liaise closely with agent and Health Authorities in KSA.
• Responsible for Change Controls for Variations for the ME region.
• Work as a deputy for the local responsible person for advertisement/promotional material.
• Deputy Local Responsible person for validation of Packaging Items.
• Cross collaboration with other ME departments.

Dimensions

• Geographical span: ME - KSA.
• Work with the ME Regulatory Lead to develop a detailed understanding of regulatory guidelines and technical requirements in KSA.
• Life cycle management of products, understanding of industry-specific regulations, audit procedures, and the ability to ensure compliance with regulatory standards.
• Work and support the KSA Regulatory Affairs team.
• Cross-functionality with other departments.
• Report to the Head of the Department.

Requirements

Educationalqualifications

• Bachelor's Degree in Pharmacy / Science.

Relevant Experience

• 3+ years of relevant pharmaceutical regulatory experience within a large multinational organization.
• Experience working in Saudi Arabia (preferred).
• Experience of working within a Global pharmaceutical company would be an advantage.

Skills & Personal characteristics

• Good knowledge of the Regulatory environment and procedures in KSA.
• Sharp Regulatory Intelligence.
• Ability to work cross functional to resolve complex issues.
• Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure, team player.
• Multi-tasking, organized, Process & Result oriented, Focused, Problem solving, good judgment and decision-making capability.
• Excellent interpersonal, Negotiation and relationship building skills.
• Excellent interpersonal, communication & digital skills.
• Written and spoken fluency in English & Arabic (French is an added advantage).

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit. All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

Company Description

Almarfa Medical is a leading organization dedicated to introducing the latest innovative medical products to specialty medical centers throughout Saudi Arabia. Our efforts are powered by a professional and highly qualified team of consultants and sales people. We operate as a full-service organization, facilitating collaboration between medical product manufacturers and hospitals across the Kingdom.

Job Purpose:

The Regulatory Affairs Specialist is responsible for ensuring that all medical devices marketed and distributed by Almarfa Medical
comply with the regulatory requirements of the
Saudi Food and Drug Authority (SFDA)
. The role focuses on the registration, renewal, and maintenance of medical device marketing authorizations, ensuring timely approvals and full regulatory compliance throughout the product lifecycle.

Job Title: Regulatory Affairs Specialist

Location: Riyadh, Saudi Arabia

Department: Regulatory Affairs

Reports To: Regulatory Affairs Manager

Key Responsibilities:

• Prepare, compile, and submit medical device registration dossiers in compliance with
  SFDA MDS-REQ-1
  , and related guidelines.
• Coordinate and communicate with SFDA reviewers during the submission and evaluation phases to address comments and provide clarifications.
• Manage the registration and licensing of new products, facilities, and importers in the
  GHAD system
  .
• Ensure proper documentation and compliance with SFDA requirements for labeling, bundling, classification, and post-market surveillance.
• Maintain and update the
  Medical Device Marketing Authorization (MDMA)
  and ensure timely renewals before expiration.
• Collaborate with manufacturers and principals to collect technical documentation, including technical files, QMS certificates, risk-management reports, and clinical evaluations.
• Review and verify compliance of Instructions for Use (IFU), packaging, and labeling with local regulatory standards.
• Monitor changes in SFDA regulations and communicate updates to internal teams and international partners.
• Support internal audits, ISO 13485:2016 compliance, and quality-management activities related to regulatory documentation.
• Keep detailed records of all submissions, approvals, and correspondences with SFDA.

Qualifications and Skills:

• Bachelor's degree
  in Pharmacy, Biomedical Engineering, Medical Sciences, or related field.
• Minimum
  2–4 years of experience
  in
  SFDA medical device registration
  or similar regulatory affairs role.
• Strong knowledge of
  SFDA Medical Device Interim Regulation
• Familiarity with ISO 13485
  and
  ISO 14971
  standards.
• Excellent written and verbal communication skills in
  English and Arabic
  .
• Strong organizational skills and attention to detail.
• Ability to manage multiple submissions and deadlines efficiently.

Preferred Attributes:

• Experience with cardiovascular, surgical, or oncology medical devices.
• Prior work in a multinational or authorized representative company.
• Proficiency in the
  SFDA GHAD platform
  and e-services.

Please send your CV to

Company Description

PharmaKnowl is a leading provider of regulatory and pharmacovigilance consultation services in Saudi Arabia.

Role Description

This is a full-time, on-site role in Riyadh, Saudi Arabia.

The Regulatory Affairs Manager will be responsible for:

• Providing strategic regulatory consultations for international pharmaceutical companies.
• Providing guidance, mentoring, and managing teams.
• Executing regulatory projects for clients.

Qualifications

• Expert in Saudi Arabia (SFDA) Pharmaceutical Regulatory Affairs.
• Bachelor's degree in Pharmacy.

Roles and Responsibilities

• Support registration processes with regulatory bodies within Saudi Arabia, for IVDs and medical devices.
• Internal and external communication to complete registration requirements.
• Update trackers and internal files for visibility of all regulatory processes.
• Support with inbound shipment regulatory operations and related communications.
• Preparation of regulatory letters and templates.

Qualifications

• Bachelor's Degree in Medical Laboratory Sciences, Biomedical Engineering or Biomedical Technology.
• High written and verbal communication skills in Arabic and English.
• Good MS Office Skills.
• Tamheer conditions apply.
• No experience required.

About Sysmex LLC

Sysmex Corporation supports healthcare professionals around the world in lighting the way with diagnostics by providing a broad range of medical diagnostic products and solutions. In the fields of Haematology, urinalysis, hemostasis, life science, flow cytometry, essential healthcare and immunochemistry, we combine highly dependable, multi-functional and easy-to-operate instruments, a variety of reagents and software, plus reliable service and support.

Sysmex LLC, located in Riyadh, Saudi Arabia, is a subsidiary of the Sysmex Corporation from Kobe, Japan. From our Riyadh offices, we serve our customers in Saudi Arabia and support healthcare professionals by providing medical diagnostic products, solutions and services.

International Reputation

Sysmex ranks among the top diagnostic companies, being a world leader in haematology diagnostics and services. Globally, the company operates in more than 190 countries and regions around the world and employs more than 10,000 people.

The company's net sales at the fiscal year ended March 2022 were 2.79 € billion (¥363.7 billion: €1=¥130), with the EMEA region accounting for 27.9% of that amount.

Company Description

Techno Orbits Co. is dedicated to providing creative healthcare solutions and quality services to our customers. Our mission is to improve the quality of care by offering best-in-class products, technology, and services. We aim to become a leader in the healthcare industry within the Kingdom of Saudi Arabia. We partner with top quality suppliers to provide exceptional solutions and employ competent staff to ensure quality services.

Role Description

This is a full-time, on-site role for a Regulatory Affairs Officer located in Riyadh, Saudi Arabia. The Regulatory Affairs Officer will be responsible for preparing and submitting regulatory documentation, ensuring compliance with regulatory requirements, and managing regulatory submissions. They will also monitor and interpret regulatory guidelines and advise on best practices to ensure compliance and continuous improvement.

Qualifications

• Experience in preparing Regulatory Documentation, Regulatory Submissions, and ensuring Regulatory Compliance
• Knowledge of Regulatory Requirements and Regulatory Affairs
• Strong attention to detail and organizational skills
• Excellent written and verbal communication skills in both English and Arabic
• Bachelor's degree in a related field (e.g., Life Sciences, Pharmacy, Regulatory Affairs)
• Previous experience in the healthcare industry is a plus
• Ability to work independently and manage multiple projects simultaneously

Key Responsibilities:

• Prepare, review, and submit regulatory applications to SFDA (MDMA, MDIL, , etc.) for medical devices and IVD products.
• Stay updated with SFDA regulations, guidelines, and global regulatory requirements.
• Ensure compliance with ISO 13485, MDSAP, and other relevant quality/regulatory standards.
• Monitor product licenses and certificates to ensure timely renewals without interruptions.
• Coordinate with internal teams, suppliers, and regulatory authorities to resolve queries.
• Support audits, inspections, and provide regulatory guidance throughout the product lifecycle.
• Maintain accurate regulatory documentation and records of all submissions.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Riyadh, Saudi Arabia

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

REGULATORY AFFAIRS SPECIALIST (MEDICAL DEVICES)

Location: Riyadh

Contract: full-time

Purpose:

The main task of a Regulatory Affairs specialist in Johnson & Johnson is Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration & importation guidance.

You will be responsible for:

• Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in Saudi Arabia or through J&J distributors when applicable
• SFDA meetings
• Clearance support to distributors
• Updating the regulatory tracking systems
• Having the renewed certificates & re-registration licenses of expired ones on time
• Responding to Change Impact Assessments before due dates
• Doing Copy Review process for promotional materials on time upon request
• Lift all regulatory restrictions for products that can be shipped to Saudi Arabia
• Tender support to commercial teams & distributors

Qualifications / Requirements:

• Education: Bachelor's (B.Sc.) degree of Biomedical engineering or Sciences
• Minimum 2 years of Regulatory Affairs experience withing Medical Devices industry
• Language: English & Arabic (fluent)
• Time Management
• Very good presentation & communication skills
• Sense of urgency, attention to details, creative problem-solving
• Collaboration & teamwork
• Self-motivation, ability to work under stress
• Involvement in Regional Projects
• Saudi national

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function
Regulatory Affairs Group

Job Sub Function
Regulatory Product Submissions and Registration

Job Category
Professional

All Job Posting Locations:
Riyadh, Saudi Arabia

Job Description
About MedTech
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

REGULATORY AFFAIRS SPECIALIST (MEDICAL DEVICES)
Location: Riyadh
Contract: full-time
Purpose
The main task of a Regulatory Affairs specialist in Johnson & Johnson is Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration & importation guidance.

You Will Be Responsible For

• Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in Saudi Arabia or through J&J distributors when applicable
• SFDA meetings
• Clearance support to distributors
• Updating the regulatory tracking systems
• Having the renewed certificates & re-registration licenses of expired ones on time
• Responding to Change Impact Assessments before due dates
• Doing Copy Review process for promotional materials on time upon request
• Lift all regulatory restrictions for products that can be shipped to Saudi Arabia
• Tender support to commercial teams & distributors

Qualifications / Requirements

• Education: Bachelor's (B.Sc.) degree of Biomedical engineering or Sciences
• Minimum 2 years of Regulatory Affairs experience withing Medical Devices industry
• Language: English & Arabic (fluent)
• Time Management
• Very good presentation & communication skills
• Sense of urgency, attention to details, creative problem-solving
• Collaboration & teamwork
• Self-motivation, ability to work under stress
• Involvement in Regional Projects
• Saudi national

Key Responsibilities

• Prepare accurate and timely responses to SFDA inquiries in coordination with relevant departments, ensuring compliance with applicable regulations and deadlines.
• Review and analyze variations received from internal departments, determine their classification (major/minor), assess required documents, and prepare variation submissions in line with SFDA guidelines.
• Compile, validate, and submit eCTD (electronic Common Technical Document) dossiers for medicinal products and herbal/health supplements.
• Monitor and follow up on regulatory submissions, price appeals, inquiries, and variation statuses with SFDA to ensure process continuity and timely approvals.
• Ensure successful execution of the product registration plan, tracking milestones and collaborating with internal stakeholders to meet objectives.
• Maintain valid registration of all products in the market, ensuring that PILs (Patient Information Leaflets), SmPCs (Summary of Product Characteristics), and artworks are continuously updated and compliant.
• Act as the regulatory liaison for product life cycle activities, post-approval changes, and renewals to support product continuity in the KSA market.
• Stay abreast of changes in local regulations and provide strategic input to management on anticipated regulatory risks or opportunities.
• Develop and maintain strong relationships with SFDA officials and regulatory consultants to support proactive and smooth regulatory interactions.
• Support audits and inspections by ensuring readiness of regulatory documentation and compliance records.

Qualifications

• This position is open exclusively to Saudi nationals.
• Bachelor's or master's degree in pharmacy, Life Sciences, or a related field.
• Minimum 1–4 years of experience in Regulatory Affairs within the pharmaceutical or healthcare sector, with at least 1 years in the KSA market.
• Strong experience in SFDA submission processes and regulations.
• Hands-on experience with eCTD compilation and publishing.
• Proven track record in handling product variations, renewals, and regulatory compliance.
• Prior experience in managing or mentoring a small team is preferred.