Accomplished professional with expertise in regulatory affairs and compliance, quality management systems, and audit and inspection. Demonstrates proficiency in licensing oversight, medical device advertising approval, and exemption approvals. Skilled in post-market surveillance, risk assessment, and stakeholder engagement. Proven leadership skills enhance networking proficiency and process improvement initiatives. Adept at budget management and multi-tasking within supply chain management contexts. Committed to advancing industry standards through strategic oversight and continuous improvement efforts.
Hi, I’m
ZAHROH HASANAH AGUSTINI NINAYA
Cyberjaya,Malaysia
Summary
Overview
19
years of professional experience
6050
years of post-secondary education
1
Certification
Work history
Medical Device Authority MalaysiaCyberjaya, Selangor
Principle Assistant Director
2025.07 - 2026.02 (7 education.months_Label)
Job overview
- Managed units for establishment, advertisement, and exemption to optimize operational efficiency.
- Evaluated establishment license applications, approving renewals and ownership transfers.
- Reviewed advertisement submissions for compliance, authorizing valid applications.
- Assessed exemption applications, validating evaluations and approving eligible requests.
- Led strategic plan development to drive business growth.
- Supervised staff training program, enhancing professional development opportunities.
- Streamlined office procedures to improve workflow efficiency.
- Maintained a network of professional connections to support organizational objectives.
Medical Device Authority MalaysiaCyberjaya, Selangor
Principle Assistant Director
2023.08 - 2025.06 (1 education.year_Label & 10 education.months_Label)
Job overview
- Monitored compliance with regulatory requirements across various platforms.
- Conducted proactive inspections to ensure adherence to industry standards.
- Oversaw compliance monitoring for online sellers, pharmacies, and border control.
- Evaluated mandatory reports and corrective actions, including product recalls.
- Issued warning letters for non-compliance and followed up on corrective actions.
- Escalated unresolved issues to enforcement for potential legal action.
- Streamlined office procedures to enhance workflow efficiency.
- Facilitated internal audits to promote financial transparency.
Medical Device Authority MalaysiaCyberjaya, Selangor
Principle Assistant Director
2019.01 - 2021.07 (2 education.years_Label & 6 education.months_Label)
Job overview
- Monitored compliance with regulatory requirements through proactive inspections at pharmacies.
- Oversaw compliance monitoring for online selling platforms to enhance operational standards.
- Issued warning letters for non-compliance and tracked corrective actions.
- Escalated unresolved issues to enforcement for potential legal action.
- Built networks with customs and law enforcement officers to improve cooperation.
- Led strategic planning initiatives to drive business growth and optimise efficiency.
- Managed staff training initiatives, fostering professional development opportunities.
- Prepared comprehensive reports for insights into organizational operations and financial transparency.
Medical Device Authority MalaysiaCyberjaya, Selangor
Principle Assistant Director
2015.01 - 2018.12 (3 education.years_Label & 11 education.months_Label)
Job overview
- Conducted audits of establishments against GDPMD and ISO 13485 standards.
- Facilitated internal audits, ensuring financial transparency and compliance.
- Streamlined office procedures to enhance workflow efficiency.
- Managed team schedules and deadlines to optimise productivity.
- Trained new team members on company mission, values, and policies.
- Identified process improvements that increased overall productivity.
- Liaised with managing directors to address project needs and communication.
- Represented organisations at seminars, conferences, and business events.
Medical Device Authority Malaysia
Assistant Director
2012.01 - 2015.01 (3 education.years_Label)
Job overview
- Managed development of medical device registration system (MeDC@St 1.0).
- Evaluated and verified establishment licence applications to ensure compliance.
- Assessed medical device registration applications for regulatory adherence.
- Formulated strategic plans and regulatory frameworks for exemptions, including special access and custom-made devices.
Medical Radiation Regulatory Branch
Assistant Director
2011.01 - 2011.01
Job overview
- Assessed licensing applications for ionizing radiation devices used in medical settings under Act 304.
Pahang State Health Department
Assistant Director
2007.01 - 2011.01 (4 education.years_Label)
Job overview
- Enforced Act 304 at state level as Radiation Safety Officer.
- Conducted proactive inspections of clinics and healthcare facilities with ionising radiation devices.
- Issued warning letters for non-conformance to safety regulations.
- Ensured compliance through statutory reporting and regulatory adherence.
- Oversaw budgeting processes, maintaining fiscal responsibility throughout operations.
- Streamlined office procedures to enhance workflow efficiency.
- Prepared comprehensive reports providing insights into organizational performance.
Education
Universiti Teknologi Mara (UiTM)
Master from Enforcement Law
University overview
I hold a Master in Enforcement Law (UiTM, 2025), completed part‑time and fully self‑funded, graduating with a CGPA of 3.52. My thesis, “A Study on the Adequacy of Medical Device Act 2012 (Act 737) in Controlling Conformity Assessment Body”, reflects my commitment to strengthening regulatory frameworks and ensuring effective oversight of conformity assessment bodies. This academic achievement complements my practical regulatory experience and demonstrates my ability to bridge policy, enforcement, and quality systems
ILKAP-UiTM
Executive Diploma from Enforcement Law
University overview
Universiti Kebangsaan Malaysia
Bachelor of Science (Hons) from Nuclear Science
University overview
Skills
- Regulatory affairs and compliance
- Quality management systems
- Audit and inspection
- Licensing oversight
- Medical device advertising approval
- Exemption approvals
- Post-market surveillance
- Risk assessment
- Stakeholder engagement
- Supply chain management
- Leadership skills
- Networking proficiency
- Process improvement
- Budget management
- Multi-tasking skills
LANGUAGES
Bahasa Malaysia Native
IELTS Band 7.0 (English)
JLPT N3 & N4 Japanese Proficiency
Accomplishments
Accomplishments
- Excellence Service Award (2015)
- Key contributor to drafting Medical Device Regulations and GDPMD framework
- Led national vigilance and post-market surveillance initiatives under Act 737
AWARDS & RECOGNITION
AWARDS & RECOGNITION
Excellence Service Award 2015 – Ministry of Health, Presented at National and International levelpublications
publications
- Procedia Chemistry Surface Modified PLA Microsphere for Drug Delivery (2016)
- Scientific.net Surface Modification via Gamma Irradiation (2017)
Courses & Training
Courses & Training
- Quality Management System ISO 13485 – BSI, 2016
- Medical Device Seminar – PMDA Japan, 2017
- Aligning Medical Device Regulation to Optimize Risk Management – University of Southern California, 2024
volunteerism & community engagement
volunteerism & community engagement
- SEA Games 2017 Kuala Lumpur – Logistics & Athlete Liaison
- MERC Malaysia – Fundraising Campaigns
- Private Madrasah Cambodia – Teaching & Food Prep
- Sports & Recreation Dare2F Program & Taekwondo Mentoring
- Ocean Cleaning Drive – Underwater Waste Recovery
Certification
Registered Radiation Safety Officer
Licensed Open Water Scuba Diving
Timeline
Principle Assistant Director
Medical Device Authority Malaysia
2025.07 - 2026.02 (7 education.months_Label)
Principle Assistant Director
Medical Device Authority Malaysia
2023.08 - 2025.06 (1 education.year_Label & 10 education.months_Label)
Principle Assistant Director
Medical Device Authority Malaysia
2019.01 - 2021.07 (2 education.years_Label & 6 education.months_Label)
Principle Assistant Director
Medical Device Authority Malaysia
2015.01 - 2018.12 (3 education.years_Label & 11 education.months_Label)
Assistant Director
Medical Device Authority Malaysia
2012.01 - 2015.01 (3 education.years_Label)
Assistant Director
Medical Radiation Regulatory Branch
2011.01 - 2011.01
Assistant Director
Pahang State Health Department
2007.01 - 2011.01 (4 education.years_Label)
Universiti Teknologi Mara (UiTM)
Master from Enforcement Law
2025.01
ILKAP-UiTM
Executive Diploma from Enforcement Law
2022.01
Universiti Kebangsaan Malaysia
Bachelor of Science (Hons) from Nuclear Science
2002.01