Salma Aya Sofia

Biomedical Engineering graduate with regulatory affairs experience in product registration, SOP development, and GMP compliance, including direct coordination with a national regulatory authority through submission, review, and audit cycles. Trained in ISO 13485 quality management systems and CDAKB principles, with hands-on medical device testing and risk assessment exposure. Detail-oriented, audit-ready, and quick to learn new regulatory frameworks.

Regulatory Affairs Staff at PT. Pesona Rasa Indonesia Sejahtera (2025-03 – 2026-06)

• Resolved recurring audit findings on incomplete submission files by compiling and preparing regulatory documents in Microsoft Word, coordinating with production and quality teams to achieve consistently audit-ready documentation.
• Streamlined SOP and submission traceability amid frequent revisions by building and maintaining a regulatory document control and filing system in Google Workspace (Docs, Sheets, Drive), improving retrieval accuracy and version control.
• Reduced compliance exposure by building Excel-based audit matrices to run structured impact assessments and identify regulatory risks, then performing regulatory writing in Word to develop and revise SOPs aligned with GMP requirements.
• Coordinated directly with a national regulatory authority (BPOM) across submission, review, and audit cycles, tracking registrations end-to-end from filing through approval using Excel-based registration trackers.

Quality Assurance Intern at C-TECH Laboratories Edwar Technology (2024-02 – 2024-06)

• Supported testing, calibration, and clinical evaluation of medical devices for brain imaging and cancer therapy, conducting hazard identification and risk assessment to confirm device safety before internal review.
• Managed patient medical record data with accuracy and confidentiality in Excel, documenting device performance findings in structured Word-based technical reports for internal review.

Bachelor of Biomedical Engineering in Biomedical Engineering – Telkom University – Purwokerto, Indonesia (2021-09 – 2025-08)