31 Regulatory Requirements jobs in Saudi Arabia
Regulatory Compliance COOP
Posted today
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Job Description
About HSBC:
HSBC Saudi Arabia provides investment banking services to the full spectrum of corporate and institutional clients in both the private and government sectors, including public companies; private companies and establishments; funds; government agencies; and family businesses and offices.
Main Responsibilities for the role:
- Support the implementation and monitoring of Compliance policies, procedures.
- Monitor CMA and Tadawul Regulatory updates and support necessary changes to internal policies and communications.
- Assist in compliance reviews, reporting, and maintenance of records.
- Support monitoring of Personal Account Dealing activities.
- Assist in providing compliance support to the business, including training and regulator requests.
Product Regulatory Compliance Specialist
Posted today
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Job Description
Company Description
About Veolia
Veolia aims to be the benchmark company for ecological transformation. Our mission to “Resource the world” demonstrates the unwavering commitment of our 220,000 employees to creating a positive impact for our planet.
By joining Veolia Water Technologies , not only will you become a Resourcer, but you will also take part in providing complete solutions for water treatment. By innovating in key areas such as sustainable development, resource and product recovery, we want to offer water related solutions suited for every application.
At Veolia Water Technologies, Saudi Arabia , we are committed to empowering our employees, to make their own decisions and to make a real difference.
Become a player in ecological transformation by joining us!
Job DescriptionThe Product Regulatory Compliance Specialist ensures our chemical products meet all regulatory requirements, particularly in the Middle East markets. This role will manage product compliance, documentation, and regulatory affairs while supporting business growth through effective compliance strategies.
Main tasks and responsibilities include but are not limited to the following:
- Essential Responsibilities:
- Ensuring manufactured products meet all regulatory standards and other certification standards (NSF etc)
- Monitoring compliance with chemical regulations (REACH, GHS, TSCA, CLP, etc.)
- Managing product safety data sheets (SDS) and other applicable regulatory documentation.
- Conducting product compliance audits and assessments.
- Reviewing raw material compliance and supplier documentation.
- Maintaining product registrations and certifications
- Collaborate with quality control and manufacturing teams.
- Creating, designing, and verifying product labelling and packaging compliance.
- Supporting customer compliance inquiries and requirements.
- Tracking regulatory changes affecting product specifications.
- Collaborating with manufacturing teams to ensure compliance in production.
- Maintaining compliance databases and documentation systems.
- Supporting new product development with compliance guidance.
- Coordinating with regulatory agencies and certification bodies.
- Developing and implementing compliance procedures.
- Training staff on compliance requirements.
- Managing chemical inventory compliance.
- Supporting safety and environmental compliance initiatives.
- Participate or lead assigned projects.
Desired Characteristics:
- Strong attention to detail and analytical skills
- Excellent project management capabilities
- Superior communication and interpersonal abilities
- Problem-solving mindset
- Ability to work independently and in teams.
- Strong organizational and documentation skills
- Adaptable to changing regulatory requirements.
- Customer-focused approach
- Ability to manage multiple priorities.
- Proactive and results-oriented attitude
Job specifications
Qualifications
- Bachelor’s degree in chemistry or chemical engineering.
- Valid GCC driver's license
Experience
- Minimum 3 years' experience in chemical regulatory compliance.
- Demonstrated experience with GCC chemical regulations and transport requirements.
- Knowledge of international chemical regulations (REACH, GHS, etc.).
- Strong understanding of chemical safety and hazard classification.
- Knowledgeable and possess training certificate and experience related to Dangerous Goods transport regulations (IMDG, IATA and ADR).
- Proficiency in both English and Arabic.
- Experience with compliance management systems.
Specific training
- Preferred candidates will have IATA, IMDG and ADR training.
QHSE Commitments:
- Implementing the QHSE policies and ISO Procedures.
- Follow the always safe rules and coach your colleagues on the same
- Follow the road traffic rules while driving to and from home to work (fasten seat belt, maintain speed limits, never use mobile / eat/drink/smoke while driving, drive in a fit condition).
- Being responsible towards Veolia’s specific sustainable development commitments.
- Ensure to read the safety moments / Alerts / other information shared by the HSE Team.
- Before visiting any site, factory, and/or warehouse, make sure to inform the safety team to get the right induction and prepare LMRA and the needed PPE.
- Always maintain office safety such as keeping your files/papers in the correct place, keeping the drawers closed after use, arranging the electrical cables secured to avoid slips & trips, reporting any lost connections or damaged electrical components, and ensuring your office is clean and tidy
- Report to HR/HSE if you are facing stress, fatigue, any form of harassment, or bullying at the workplace.
Veolia Code of Conduct
- Comply with applicable ethics and legislation referred to in Veolia Code of Conduct policy, particularly in the fight against corruption and influence peddling.
As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.
#J-18808-LjbffrSenior Regulatory Compliance Manager
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Arthur Lawrence is urgently looking for a Senior Regulatory Compliance Manager for a client in Riyadh, KSA.
- Kindly review the Job requirements below.
Your immediate application will enable us to place you successfully.
Must-Have : 10+ years of experience in a regulatory compliance, legal, or risk management role within financial services or fintech.
Strong knowledge of Saudi financial regulatory frameworks (SAMA), particularly Consumer Protection regulations.
Experience working closely with product, engineering, and legal teams in a fast-paced, agile environment.
Proven ability to interpret regulatory requirements and design practical compliance solutions.
Excellent communication and stakeholder management skills, including experience interfacing with regulators or banking partners.
Ability to work independently, make sound decisions, and manage competing priorities.
Nice to have : Bachelors degree in Business Administration, Law, Finance, or Accounting Certifications in CRCM, CAMS, CRCMP, or PMP preferred About Us : Arthur Lawrence is a management and technology consulting firm providing enterprise-wide business transformation and business applications implementation services.
Our in-depth technical knowledge and broad experience of working with world-class companies enables organizations to leverage our capabilities in developing winning strategies and cost-effective solutions.
We are an UN Women Empowerment Principal Signatory and are certified from National Minority Supplier Development Council.
Acknowledgements from Industry Peers : Winner of Entrepreneur 360 Award (2019).
IAOP Award; Ranked in top 100 internationally.
Arthur Lawrence ranked within the Inc 5000 twice in 2016 and 2017 as one of the fastest.
Growing companies of America.
Named one of the top ten fastest growing businesses in Houston in 2016.
Ranked 25th in the HBJ s Fast 100 Private Companies Award in 2017.
Our Seven Pillars : We rely on the seven core values that we believe enable us to deliver quality for our consultants and clients : Education, Integrity, Value Creation, Collaboration, Best Client, Best People and Stewardship Through strict adherence to these core values, we have achieved success beyond all documented forecasts and anticipation.
#J-18808-LjbffrSenior Manager Regulatory Compliance Retail
Posted today
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Job Description
Job Description & Accountabilities
- Senior Manager Regulatory Compliance leads a small group of compliance professionals for Retail Banking Group Compliance areas. This role plans, implements and follows up on Compliance issues is typically the content expert for his area of responsibility.
- This role is responsible for all testing and monitoring mandated under the Compliance control. He/she will also suggest appropriate areas (identified through their testing and monitoring process) to address in order to prevent further breaches of SAMA rules, policies and external regulations and to ensure implementing the controls in the right methods.
- This role is a senior professional with significant compliance and people management capabilities. This position reports directly to the Head of Regulatory Compliance.
- Enhances the effectiveness of the compliance risk by arranging risk assessments and identifies controls in place to mitigate identified risks.
- Works closely with the Businesses on new, existing services, products to analyze the risk elements and advise them on any actions needed.
- Promptly reports any suspicious activity and issues in due diligence standards to the Head of Compliance.
- Supports the Manager in any ad-hoc projects to promote the compliance culture within the BSF, during inspection visits (internal and external) to the bank or to fulfil any compliance reporting requirement from the senior management.
- Responsible to entertain the Internal and External Auditors and the regulator's Inspectors professionally and tactfully during their inspection visits.
- Provides direction, guidance to his team on delivering the department's responsibilities and arranges appropriate control self-assessment meetings and trainings for Compliance team.
- Ensures that all testing and monitoring are undertaken effectively and ensures all reports are submitted complete, accurately and on time.
- Develops and maintains comprehensive procedures to avoid any misunderstanding for the staff members involved.
- Responsible for keeping detailed records of all compliance testing and reviews, and provides timely and professional responses to all requests.
- Supervises Compliance officers work closely with the Businesses on new and existing services and products to analyze the risk elements and advises them on any actions needed.
- Ensures that all BSF standards and requirements are met by each member of the department.
- Reviewing related policies and procedures, documents, agreements, forms, terms and conditions, marketing materials and contracts.
- Provide advice to business line from regulatory prospective.
Validating implementation of related SAMA circulars and collected evidences as per compliance procedure manual.
Qualifications & Experience:
- Bachelor Degree in Finance or Business
- 8-10 years banking experience in related field
- 5-7 years within Compliance/Audit areas of the bank
Knowledge & Skills:
- Excellent understanding of the Retail, Wealth Management and High Net Work areas and products/services
- Excellent analytical and investigative skills
- Seasoned experience of writing policies and departmental documents in compliance with regulations
- Excellent analytical skills to interpret the regulations/banking laws of the Kingdom
- Good understanding of all the compliance fields
- Sound experience of meeting tight deadlines and working under pressure
- Excellent computer/Microsoft skills
- Sound experience of leading teams
- Good Project management skills
Senior Manager Regulatory Compliance Retail
Posted today
Job Viewed
Job Description
Job Description & Accountabilities:
- Senior Manager Regulatory Compliance leads a small group of compliance professionals for Retail Banking Group Compliance areas. This role plans, implements and follows up on Compliance issues is typically the content expert for his area of responsibility.
- This role is responsible for all testing and monitoring mandated under the Compliance control. He/she will also suggest appropriate areas (identified through their testing and monitoring process) to address in order to prevent further breaches of SAMA rules, policies and external regulations and to ensure implementing the controls in the right methods.
- This role is a senior professional with significant compliance and people management capabilities. This position reports directly to the Head of Regulatory Compliance.
- Enhances the effectiveness of the compliance risk by arranging risk assessments and identifies controls in place to mitigate identified risks.
- Works closely with the Businesses on new, existing services, products to analyze the risk elements and advise them on any actions needed.
- Promptly reports any suspicious activity and issues in due diligence standards to the Head of Compliance.
- Supports the Manager in any ad-hoc projects to promote the compliance culture within the BSF, during inspection visits (internal and external) to the bank or to fulfil any compliance reporting requirement from the senior management.
- Responsible to entertain the Internal and External Auditors and the regulator's Inspectors professionally and tactfully during their inspection visits.
- Provides direction, guidance to his team on delivering the department's responsibilities and arranges appropriate control self-assessment meetings and trainings for Compliance team.
- Ensures that all testing and monitoring are undertaken effectively and ensures all reports are submitted complete, accurately and on time.
- Develops and maintains comprehensive procedures to avoid any misunderstanding for the staff members involved.
- Responsible for keeping detailed records of all compliance testing and reviews, and provides timely and professional responses to all requests.
- Supervises Compliance officers work closely with the Businesses on new and existing services and products to analyze the risk elements and advises them on any actions needed.
- Ensures that all BSF standards and requirements are met by each member of the department.
- Reviewing related policies and procedures, documents, agreements, forms, terms and conditions, marketing materials and contracts.
- Provide advice to business line from regulatory prospective.
- Validating implementation of related SAMA circulars and collected evidences as per compliance procedure manual.
Regulatory Affairs Specialist
Posted today
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Job Description
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.
What will you be doing?
- 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.
What will you need to be successful?
- Bachelor's degree in Biomedical Engineering, Pharmacy, or a related
- 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
Stay connected by joining our Talent Community.
We're more than just a company - we're 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 and learn more about our mission, our team, and the opportunities we offer.
Regulatory Affairs Specialist
Posted today
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Job Description
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.
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Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
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.
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
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
Regulatory Affairs Manager
Posted today
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Job Description
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.