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Regulatory Affairs Officer
Ameesa Medical Corp.
Jeddah, KSA
Full Time
Entry
Onsite
2 weeks ago
Regulatory DocumentationRegulatory SubmissionsSFDAMDMAMDILGhad platform
Free
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Regulatory DocumentationRegulatory SubmissionsSFDA
About the Role
Ameesa Medical Corp. is seeking a Regulatory Affairs Officer for a full-time, on-site role in Jeddah. The position involves preparing and maintaining regulatory documentation, coordinating submissions with the SFDA, and ensuring compliance with local and international regulations.
Key Skills for This Role
Regulatory DocumentationRegulatory SubmissionsSFDAMDMAMDILGhad platform
Responsibilities
- Prepare, review, and maintain regulatory documentation to support product registrations and approvals
- Coordinate regulatory submissions with health authorities (SFDA)
- Monitor regulatory changes and ensure ongoing compliance of products and processes
- Collaborate with internal teams and external partners
- Maintain regulatory databases and records
- Support audits and inspections
- Provide guidance on regulatory requirements for new and existing products
- Contribute to risk assessments, product labeling reviews, and quality improvement initiatives
Requirements
- Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related discipline
- Strong skills in Regulatory Documentation and Regulatory Submissions
- Experience in issuing MDMA, MDIL, and AR medical licenses on the Ghad platform
- Robust knowledge of Regulatory Compliance and Regulatory Requirements
- Solid understanding of Regulatory Affairs practices, including lifecycle management of medical products
- Experience in medical devices or cardiovascular products is preferred
- Effective written and verbal communication skills in English; Arabic proficiency is an advantage
Full Job Posting
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.
Key Responsibilities
- Prepare, review, and maintain regulatory documentation to support product registrations and approvals.
- Coordinate regulatory submissions with health authorities (SFDA).
- Monitor regulatory changes and ensure ongoing compliance of products and processes.
- Collaborate with internal teams and external partners.
- Maintain regulatory databases and records.
- Support audits and inspections.
- Provide guidance on regulatory requirements for new and existing products.
- Contribute 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.
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