47 Financial Regulations jobs in Saudi Arabia

We are seeking a detail-oriented and experienced Regulatory Affairs Officer to join our team in Jeddah. The ideal candidate will be responsible for managing all regulatory activities related to medical devices and healthcare products, ensuring full compliance with SFDA (Saudi Food & Drug Authority) and other relevant authorities.

• Prepare, submit, and follow up on MDMA (Medical Device Marketing Authorization) applications with SFDA.
• Coordinate and maintain product registrations, renewals, and variations in compliance with local regulations.
• Ensure all products meet SFDA, GHTF, IMDRF and international regulatory requirements.
• Liaise with suppliers, manufacturers, and distributors to obtain and compile regulatory documentation.
• Manage the importation process, including preparation and submission of clearance documents for shipment release.
• Follow up with customs brokers, clearing agents, and SFDA inspectors to ensure timely clearance of shipments.
• Ensure correct labeling, documentation, and product classification according to SFDA guidelines.
• Monitor regulatory updates, circulars, and announcements to ensure company compliance at all times.
• Assist in audits, inspections, and internal compliance reviews.
• Maintain a regulatory database and proper filing system for all approvals, licenses, and permits.

• Bachelor's degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
• Proven experience (2-4 years) in Regulatory Affairs within the medical device (NEW IVDR REGULATIONS) in KSA.
• Strong knowledge of SFDA e-portal (GHAD, MDMA, SABER) and customs clearance procedures.
• Excellent communication skills in both English and Arabic.
• Strong organizational skills and attention to detail.
• Ability to work independently and handle multiple regulatory projects simultaneously.

• Competitive salary and benefits package.
• Opportunity to grow within a dynamic and expanding organization.
• A professional and collaborative work environment.

1. Functioning independently with a high degree.
2. Assigning markets, ensuring timely file preparation, requirements preparation & submissions for Pharma Products, Cosmetic, Healthcare/Herbal, Medical Device & Food.
3. Tracking the SFDA & GHC registered files. (New Submissions – Variations – Renewals).
4. Ensuring high quality labeling, translation, updating & artwork management for assigned markets.
5. ensuring providing support documents for the export market such as export permits, CPP's, FSC's & GMP's for assigned markets.
6. Communicating with the SFDA, GHC and appropriate follow up for different matters.
7. Maintain cooperative and productive relationships with the other departments in the company.
8. Maintenance/records of Regulatory Documents.
9. Working with the SFDA & GHC software systems such as (eSDR, GHAD, TAAWON, T&D, FASEH, DENR, etc.).
10. Archiving system and backups.
11. Communicating with factory (QA, R&D, etc.).
12. Following up with the SFDA & GHC for new guidelines.
13. Working knowledge of handling eCTD software.
14. Finalizing & follow up with SFDA & GHC to upload our products onto the system.
15. Submit & finalizing the approval for our products with SFDA & GHC.
16. Experience in preparing and evaluating SFDA & GHC dossier (from M1-M5).
17. Preparing letters & follow up with SFDA & GHC if there is any technical issues or if we need any meeting with them.

The Regulatory Affairs Specialist plays a crucial role in ensuring that medical and healthcare equipment complies with all regulations and standards set by governmental and international bodies. This position involves a deep understanding of the regulatory landscape and the ability to navigate complex compliance requirements. The specialist will be responsible for preparing and submitting regulatory documents, managing product registrations, and ensuring that all products meet safety and efficacy standards before they reach the market. This role is essential for maintaining the company's reputation and ensuring the safety of healthcare products.

Responsibilities:

1. Prepare and submit regulatory documents to ensure compliance with local and international regulations.
2. Manage product registrations and maintain up-to-date records of regulatory submissions.
3. Conduct thorough reviews of product labeling and promotional materials for compliance.
4. Collaborate with cross-functional teams to ensure that product development aligns with regulatory requirements.
5. Monitor changes in regulations and assess their impact on the company's products.
6. Provide guidance and training to internal teams on regulatory requirements and best practices.
7. Prepare for and participate in regulatory inspections and audits.
8. Develop and maintain relationships with regulatory agencies.
9. Assist in the preparation of responses to regulatory inquiries and issues.
10. Support the development of regulatory strategies for new products and market expansions.

Preferred Candidate:

1. Strong analytical and problem-solving skills.
2. Excellent communication and interpersonal abilities.
3. Detail-oriented with a high level of accuracy.
4. Ability to work independently and manage multiple projects simultaneously.
5. Proficient in regulatory documentation and submission processes.
6. Experience in the medical device or healthcare industry.
7. Knowledge of quality management systems and standards.
8. Ability to adapt to changing regulations and industry trends.
9. Strong organizational skills and time management.
10. Commitment to continuous professional development in regulatory affairs.

Skills

• In-depth knowledge of regulatory requirements for medical devices.
• Strong understanding of quality management systems (QMS) ISO 13485.
• Proficient in regulatory submission software and tools.
• Excellent written and verbal communication skills.
• Ability to interpret complex regulations and guidelines.
• Strong project management skills.
• Familiarity with clinical trial processes and documentation.
• Ability to work collaboratively in a team environment.

The Regulatory Affairs Specialist plays a crucial role in ensuring that medical and healthcare equipment complies with all regulations and standards set by governmental and international bodies. This position involves a deep understanding of the regulatory landscape and the ability to navigate complex compliance requirements. The specialist will be responsible for preparing and submitting regulatory documents, managing product registrations, and ensuring that all products meet safety and efficacy standards before they reach the market. This role is essential for maintaining the company's reputation and ensuring the safety of healthcare products.

Responsibilities:

1. Prepare and submit regulatory documents to ensure compliance with local and international regulations.
2. Manage product registrations and maintain up-to-date records of regulatory submissions.
3. Conduct thorough reviews of product labeling and promotional materials for compliance.
4. Collaborate with cross-functional teams to ensure that product development aligns with regulatory requirements.
5. Monitor changes in regulations and assess their impact on the company's products.
6. Provide guidance and training to internal teams on regulatory requirements and best practices.
7. Prepare for and participate in regulatory inspections and audits.
8. Develop and maintain relationships with regulatory agencies.
9. Assist in the preparation of responses to regulatory inquiries and issues.
10. Support the development of regulatory strategies for new products and market expansions.

Preferred Candidate:

1. Strong analytical and problem-solving skills.
2. Excellent communication and interpersonal abilities.
3. Detail-oriented with a high level of accuracy.
4. Ability to work independently and manage multiple projects simultaneously.
5. Proficient in regulatory documentation and submission processes.
6. Experience in the medical device or healthcare industry.
7. Knowledge of quality management systems and standards.
8. Ability to adapt to changing regulations and industry trends.
9. Strong organizational skills and time management.
10. Commitment to continuous professional development in regulatory affairs.

Skills

• In-depth knowledge of regulatory requirements for medical devices.
• Strong understanding of quality management systems (QMS) ISO 13485.
• Proficient in regulatory submission software and tools.
• Excellent written and verbal communication skills.
• Ability to interpret complex regulations and guidelines.
• Strong project management skills.
• Familiarity with clinical trial processes and documentation.
• Ability to work collaboratively in a team environment.

Overview

Join to apply for the Regulatory Affairs Specialist role at Smith+Nephew .

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

The Regulatory Affairs Specialist is responsible for ensuring timely product registration and sustained regulatory compliance across the MENA region, with a focus on Saudi Arabia. This role supports business continuity by securing licenses, handling regulatory submissions, and maintaining positive relationships with local health authorities.

• Secure timely registration of new products in accordance with strategic plans.
• Ensure uninterrupted market access through proactive license renewals and tender documentation support.
• Monitor and interpret new and existing regulations, ensuring business alignment and readiness.
• Manage post-market regulatory activities and documentation to uphold compliance.
• Identify and mitigate regulatory risks impacting product lifecycle or market access.
• Maintain positive relationships with health authorities and regulatory bodies across the region.
• Collaborate cross-functionally with Global RA, distributors, and commercial teams to streamline regulatory processes.
• Support regulatory activities for import permits and tender submissions.
• Maintain and update central regulatory databases and product information systems.
• Contribute to the development of regional regulatory strategies in alignment with global objectives.

• Bachelor’s degree in Biomedical Engineering, Pharmacy, or a related field.
• Saudi Arabian nationality.
• Minimum 1 year of experience in regulatory affairs for medical devices.
• Consistent track record in regulatory submissions and compliance with regional health authority requirements.
• In-depth knowledge of SFDA regulations and MENA regional requirements.
• Familiarity with Quality Management System requirements in accordance with ISO 13485 and Good Distribution Practice (GDP).
• Strong understanding of post-market surveillance obligations.
• Experience with product registration and documentation for the KSA market.
• Proficient in English (written and spoken).

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

We are committed to welcoming, celebrating and thriving on diversity. Learn more about our Employee Inclusion Groups on our website.

Annual bonus, company stock saving plan.

Paid volunteering hours, flexible approach.

Employee Assistance Program.

Possibility of working in a hybrid model.

Hands-On, Team-Customized.

Referral bonus, recognition program, mentoring program.

Stay connected by joining our Talent Community. We are more than just a company — we are a community. Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited. , life, culture, and benefits at S+N. Explore our website to learn more about our mission, our team, and the opportunities we offer.

• Seniority level: Associate
• Employment type: Full-time
• Job function: Project Management and Product Management
• Industries: Medical Equipment Manufacturing

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Overview

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

The Regulatory Affairs Specialist is responsible for ensuring timely product registration and sustained regulatory compliance across the MENA region, with a focus on Saudi Arabia. This role supports business continuity by securing licenses, handling regulatory submissions, and maintaining positive relationships with local health authorities.

• Secure timely registration of new products in accordance with strategic plans.
• Ensure uninterrupted market access through proactive license renewals and tender documentation support.
• Monitor and interpret new and existing regulations, ensuring business alignment and readiness.
• Manage post-market regulatory activities and documentation to uphold compliance.
• Identify and mitigate regulatory risks impacting product lifecycle or market access.
• Maintain positive relationships with health authorities and regulatory bodies across the region.
• Collaborate cross-functionally with Global RA, distributors, and commercial teams to streamline regulatory processes.
• Support regulatory activities for import permits and tender submissions.
• Maintain and update central regulatory databases and product information systems.
• Contribute to the development of regional regulatory strategies in alignment with global objectives.

• Bachelor’s degree in Biomedical Engineering, Pharmacy, or a related field.
• Saudi Arabian nationality.
• Minimum 1 year of experience in regulatory affairs for medical devices.
• Consistent track record in regulatory submissions and compliance with regional health authority requirements.
• In-depth knowledge of SFDA regulations and MENA regional requirements.
• Familiarity with Quality Management System requirements in accordance with ISO 13485 and Good Distribution Practice (GDP).
• Strong understanding of post-market surveillance obligations.
• Experience with product registration and documentation for the KSA market.
• Proficient in English (written and spoken).

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion and Belonging: committed to welcoming, celebrating and thriving on diversity, learn more about our Employee Inclusion Groups on our website.

Your Future : annual bonus, company stock saving plan

Work / Life Balance : paid volunteering hours, flexible approach

Your Wellbeing : Employee Assistance Program

Flexibility : possibility of working in hybrid model

Training : Hands-On, Team-Customized

Extra Perks : referral bonus, recognition program, mentoring program

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.

• 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.

About the Role

Support the registration, maintenance, and compliance of pharmaceutical products with the SFDA and regional health authorities—driving timely submissions, approvals, and adherence to all regulatory requirements.

• Manage product registrations, renewals, variations, and pricing submissions to SFDA and GCC authorities.
• Serve as the primary liaison with SFDA for Scientific Office and Regulatory Affairs communications, including handling and closing authority queries.
• Oversee market maintenance obligations, such as shortage notifications and related compliance requirements.
• Ensure compliance of both promotional and non-promotional activities (materials, events, digital content) with SFDA regulations.
• Coordinate with QA, Medical, Marketing, and Supply Chain teams to collect documentation, support submissions, and maintain accurate records and archives.
• Monitor regulatory updates and translate them into practical internal actions (e.g., SOPs, templates, brief trainings).

• BSc Pharmacy / PharmD
• 1–3 years of Regulatory Affairs experience in the Saudi market; export market exposure is a plus.
• Familiarity with Scientific Office obligations and SFDA e-services; working knowledge of eCTD/RIM is an advantage.
• Strong organization, attention to detail, and stakeholder communication (Arabic & English).

Overview

Join to apply for the Regulatory Affairs Specialist role at California Greens .

California Greens Corp. is a leading pharmaceutical and nutraceutical manufacturer with headquarters in New Jersey, USA, and a state-of-the-art production facility in Sudair City for Industry and Businesses, Saudi Arabia. We are committed to delivering high-quality products across the MENA region.

• Lead and manage all Regulatory Affairs activities in Saudi Arabia and the MENA region.
• Coordinate product registration processes in collaboration with local agents and regulatory authorities.
• Liaise with the Saudi Food and Drug Authority (SFDA) and other regional regulatory bodies to monitor, follow up, and expedite product (SKU) registrations.
• Respond to regulatory inquiries and ensure the timely resolution of any issues raised by authorities.
• Prepare, review, and submit regulatory dossiers and documentation in full compliance with local and regional requirements.

• Bachelor’s degree in a scientific or medical field (Pharmacy, Chemistry, Biology).
• Minimum of 3 years of hands-on experience in Regulatory Affairs, specifically with SFDA, within the pharmaceutical or nutraceutical sector.
• Strong understanding and practical knowledge of SFDA, GCC, and MENA regulatory frameworks and guidelines.
• Proficiency in Microsoft Office Suite and regulatory submission platforms.

• Fluency in both English and Arabic (written and spoken) is essential.

• Mid-Senior level

• Full-time

• Legal

• Pharmaceutical Manufacturing