Regulatory Affairs Officer

Position Overview

We are seeking a highly motivated and detail-oriented Regulatory Affairs Officer to join our dynamic team in Jeddah. This full-time, on-site position plays a pivotal role in ensuring our products meet all local and international regulatory standards. The Regulatory Affairs Officer will be responsible for preparing, reviewing, and maintaining comprehensive regulatory documentation to support product registrations and approvals. This role requires close collaboration with health authorities, including the Saudi Food & Drug Authority (SFDA), to ensure seamless regulatory submissions and ongoing compliance with evolving regulations.

Key Responsibilities

• Regulatory Documentation & Submissions: Prepare, review, and organize regulatory files for submission to health authorities, ensuring accuracy, completeness, and adherence to timelines. Experience with issuing MDMA, MDIL, and AR medical licenses on the Ghad platform is essential.
• Regulatory Coordination & Communication: Act as the primary point of contact for regulatory interactions with external partners and health authorities. Maintain official correspondence with the SFDA to address inquiries, resolve challenges, and facilitate smooth approval processes.
• Compliance & Risk Management: Monitor regulatory changes and assess their impact on products and processes. Contribute to risk assessments, product labeling reviews, and quality improvement initiatives to ensure continuous compliance with regulatory requirements.
• Database & Record Management: Maintain and update regulatory databases and records to ensure traceability and accessibility of critical information. Support audits and inspections by providing accurate and up-to-date documentation.
• Cross-Functional Collaboration: Work closely with internal teams, including R&D, Quality Assurance, and Manufacturing, to provide guidance on regulatory requirements for new and existing products. Facilitate effective communication to align all stakeholders with regulatory strategies.
• Lifecycle Management: Support the lifecycle management of medical products by ensuring regulatory compliance at every stage, from development to post-market surveillance. Stay abreast of regional and international regulatory trends to proactively address potential challenges.

Qualifications & Skills

To excel in this role, candidates must possess a strong academic background and practical experience in regulatory affairs. The ideal candidate will meet the following criteria:

• Education: Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field. Advanced degrees or certifications in Regulatory Affairs are a plus.
• Experience: Proven experience in regulatory documentation, submissions, and compliance, particularly within the medical devices or cardiovascular products sector. Familiarity with regional (e.g., SFDA) and international regulatory frameworks is highly desirable.
• Technical Proficiency: Hands-on experience with regulatory platforms such as the Ghad system for issuing medical licenses. Strong skills in preparing and organizing regulatory files for health authority submissions.
• Analytical & Organizational Abilities: Exceptional attention to detail, accuracy, and the ability to manage multiple deadlines in a fast-paced environment. Proficiency in conducting risk assessments and interpreting complex regulatory requirements.
• Communication & Collaboration: Excellent written and verbal communication skills in English. Proficiency in Arabic is advantageous for effective interaction with local authorities and stakeholders. Ability to work collaboratively with cross-functional teams to drive regulatory success.
• Regulatory Knowledge: A solid understanding of regulatory affairs practices, including lifecycle management of medical products and coordination with regulatory bodies. Stay updated on changes in regulations to ensure proactive compliance.

If you are a proactive professional with a passion for regulatory excellence and a commitment to ensuring product safety and compliance, we invite you to apply for this critical role in our team.