Portfolio and Insights

šŸŽ“ About Me

Hello! I’m Syafina Yazid, a Regulatory Affairs professional with a passion for clear, compliant, and efficient medical device submissions. I specialize in regulatory strategy, submissions and consulting for medical devices and in-vitro diagnostics (IVDs) across Malaysia (MDA) and Singapore (HSA).

Over the past few years, I’ve played a hands-on role in over 90 successful pre-market registrations and post-approval change submissions, across all risk classes, ensuring documentation is aligned with national regulations and international standards. I take pride in delivering structured, submission-ready dossiers while facilitating smooth communication between manufacturers, regulatory authorities, and Conformity Assessment Bodies (CABs).

This blog is a curated space to showcase my work, share regulatory updates, and connect with professionals and manufacturers who value regulatory precision.

šŸ“Š Project Overview

Below are visual summaries of my regulatory contributions, demonstrating the diversity and complexity of projects I’ve handled.

Malaysia (MDA):
  • Gantt Chart showing concurrent submission timelines across multiple projects from June 2024 to June 2025.

  • Pie Charts distribution by Risk Class and Medical Device Category across all past projects.

Singapore (HSA):
  • Gantt Chart showing concurrent submission timelines across multiple projects from June 2024 to June 2025.

  • Pie Charts categorized by Risk Class and Medical Specialty Area across all past projects.

šŸ“„ Experience Highlights

Regulatory Affairs Associate
FreyrSolutions Sdn Bhd | June 2024 – June 2025 (Remote)
  • Delivered over 20 medical device submissions in Malaysia and Singapore, ensuring full alignment with MDA and HSA regulatory pathways.
  • Initiated and implemented a suite of documentation templates, checklists, and recordkeeping trackers, resulting in a 100% improvement in submission efficiency and compliance consistency.
  • Acted as the Subject Matter Expert and key regulatory advisor to clients and internal teams, providing strategic and technical guidance to ensure smooth project execution.
  • Successfully addressed authority queries and coordinated with CABs and regulatory authorities, enabling 50% faster approval turnaround.
  • Spearheaded GDPMD QMS implementation in Malaysia, achieving 100% compliance during audit, and authored SOPs for post-market surveillance activities in Singapore.

Regulatory & Quality Associate
ARQon Medtech Sdn Bhd | Jan 2023 – June 2024 (Hybrid)
  • Led regulatory projects for general and IVD medical devices, resulting in over 60 successful product submissions.
  • Reviewed and compiled submission dossiers, with a 75% first-pass approval rate.
  • Collaborated directly with clients, CABs, and regulatory authorities to resolve technical queries and accelerate approval timelines by 25%.
  • Provided prompt and compliant responses to authority queries and post-market reporting requirements.
  • Contributed to APAC-wide regulatory administration during a 6-month attachment at Philips APAC Centre, optimizing documentation processes by 25% across the region.

šŸŒŸ Skills, Strengths & Education

Core Competencies:
  • Strong command of regulatory strategy planning, dossier preparation (CSDT), and submission execution.
  • Experienced in GDPMD QMS, ASEAN MDD, and regional regulatory frameworks.
  • Familiar with a wide range of device categories, including IVDs, and across all device classes (A to D).
  • Skilled in multi-project coordination, stakeholder communication (internal + external), and technical troubleshooting.
  • Proficient in developing user-friendly templates, checklists, and automated trackers for workflow efficiency.

Education:
Bachelor of Applied Science (Hons.) Industrial Chemistry
Universiti Malaysia Pahang
  • CGPA: 3.67 — First Class Honours

Diploma in Science (Major in Biology)
Universiti Teknologi MARA
  • CGPA: 3.88 — Vice Chancellor’s Award

✉️ Let’s Connect

If you’re interested in working together or learning more about my experience, feel free to reach out via the platforms below:

Thank you for visiting my portfolio!