Portfolio and Insights

🎓 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.

📊 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.

📄 Experience Highlights

Regulatory Affairs Associate
Freyr Solutions 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.

🌟 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 / 4.00 — First Class Honours

Diploma in Science (Major in Biology)
Universiti Teknologi MARA
  • CGPA: 3.88 / 4.00 — 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!