وظيفة مسؤول شؤون تنظيمية لدى Ameesa Medical Corp. في جدة

Role Description:

The Regulatory Affairs Officer is a full-time, on-site role based in Jeddah. This role is responsible for preparing, reviewing, and maintaining regulatory documentation to support product registrations and approvals in line with local and international regulations. The Regulatory Affairs Officer will coordinate regulatory submissions with health authorities (SFDA), monitor regulatory changes, and ensure ongoing compliance of products and processes. Daily tasks include collaborating with internal teams and external partners, maintaining regulatory databases and records, supporting audits and inspections, and providing guidance on regulatory requirements for new and existing products. The role also involves contributing to risk assessments, product labeling reviews, and quality improvement initiatives related to regulatory affairs.

Qualifications

• Candidates should possess strong skills in Regulatory Documentation and Regulatory Submissions, including preparing, reviewing, and organizing files for authorities.
• Communicating via email with external companies, possessing experience in issuing MDMA, MDIL, and AR medical licenses on the Ghad platform, and maintaining official communication with the SFDA to resolve any issues or challenges the company may face.
• Candidates should possess robust knowledge of Regulatory Compliance and Regulatory Requirements, with the ability to interpret and apply relevant laws, standards, and guidelines.
• Candidates should possess a solid understanding of Regulatory Affairs practices, including lifecycle management of medical products and coordination with regulatory bodies.
• Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related discipline.
• Experience in medical devices or cardiovascular products is preferred, with familiarity with regional and international regulations.
• Strong analytical, documentation, and organizational skills, with attention to detail and accuracy.
• Effective written and verbal communication skills in English; Arabic proficiency is an advantage.
• Ability to work collaboratively with cross-functional teams and manage multiple regulatory tasks and deadlines.