28 Regulatory Writing jobs in Saudi Arabia

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description
3M Health Care is now Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You'll Make in this Role
We are looking for a
Clinical Documentation Integrity Specialist
to join us in Saudi Arabia. This is an important Client facing role that requires travel to our Clients in the Country (25% - 40% of the time).

The CDI Specialist is responsible for reviewing clinical documentation to ensure completeness, accuracy, and compliance with coding and regulatory standards. The goal is to support accurate code assignments, and DRGs.

As part of Solventum CDI consulting team, this role involves conducting chart reviews for hospitals and transferring knowledge to different clients' CDI teams to help strengthen their documentation practices and long-term program effectiveness.

Key Competencies

• Excellent clinical & coding knowledge
• Confident communicators able to engage clinicians and CDI professionals
• Clinically and analytically sharp
• Comfortable in dynamic, client-facing roles
• Professional and dependable under tight audit timelines

As a CDI Specialist, You Will Have The Opportunity To Tap Into Your Curiosity And Collaborate With Some Of The Most Innovative And Diverse People Around The World. Here, You Will Make An Impact By

• Conducting retrospective chart reviews (inpatient and/or outpatient) to assess accuracy, completeness, and specificity of clinical documentation.
• Applying knowledge of ICD-10-AM/ACHI and AR-DRG classification systems to identify documentation and coding gaps.
• Shadowing physicians, coders, and CDI staff to understand current workflows and documentation practices.
• Interviewing key stakeholders (e.g., CDI team, coding team, clinicians, department heads) to gather insights into existing documentation challenges.
• Evaluating the effectiveness of hospitals CDI processes and identify areas for improvement.
• Developing structured queries and feedback where clarification or additional documentation is needed.
• Compiling audit findings into clear, actionable reports including identified gaps, risks, and recommendations.
• Conducting knowledge transfer sessions to educate client teams on best practices in documentation and compliance.
• Collaborating with the project management team to ensure consistency and quality across project engagements.
• Maintain strict confidentiality and data security in handling patient records and hospital information.

Your Skills And Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor's Degree or higher in nursing, medicine, paramedical sciences, or a related clinical field
• CDI Certification (CCDS, CDIP, or equivalent)
• Minimum 3 years of Clinical Documentation Integrity (CDI) or clinical coding experience
• Completion of HIMAA ICD-10-AM/ACHI Coding Training or equivalent
• Strong understanding of ICD-10-AM/ACHI, AR-DRG methodologies, and clinical coding principles, and coding guidelines e.g. Australian coding standards ASC, National coding advice NCA
• Experience reviewing and querying clinical documentation
• Ability to conduct structured interviews and workflow observations with hospital staff
• Proficiency in writing audit summaries and presenting findings professionally
• Knowledge and experience to navigate computer applications including abstracting and encoding software, DRG grouper software, and hospital information systems HIS
• Fluency in written and spoken English
• Proficiency with Microsoft Office suite

Additional qualifications that could help you succeed even further in this role include:

• Certification in coding: AAPC, HIMAA, AHIMA or equivalent
• Certification in Health Information Management with one of the following: RHIA or RHIT, CHIM or equivalent
• Experience working in a consulting, audit, or third-party CDI service model
• Familiarity with EMRs and CDI tools
• Background in delivering training or knowledge transfer to CDI or clinical teams
• Arabic language is a plus

Work location:
Hybrid

Travel:
National travel is required (25-40%)

Must be legally authorized to work in country of employment.

Supporting Your Well-being
Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Diversity & Inclusion
(*) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, age, civil status, disability, family status, or membership of the travelling community.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of

. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
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Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.

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terms.

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.

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