Alan Yik
Senior Regulatory Affairs Specialist @Magstim
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WORK HISTORY
Senior Regulatory Affairs Specialist @Magstim
Regulatory Intelligence- Monitoring changes in global regulatory requirements and communicate impact to the organisationGlobal Registration- Prepare dossier for the product registration in health authorities (510(k), EU MDR, UKCA, Health Canada.etc)Compliance and Quality- Act as an auditor in the internal audit to ensure the QMS is complied to the relevant quality standard/ regulation (21 CFR Part 820, ISO 13485, MDSAP regions.etc)- Host external audit to assess compliance with regulatory standardsNew Product Development/ Product Life Cycle Management- Act at the SME to develop and execute regulatory strategies for new and existing devices- Collaborate with the project team to ensure the finished device comply to the relevant regulations/ standards- Coordinate FSCA to ensure the safety and compliance of devices
EDUCATION
The Chinese University of Hong Kong
Bachelor's degree
The Chinese University of Hong Kong
Master's degree
ABOUT ALAN YIK
As a Senior Regulatory Affairs Specialist at Magstim, I apply my 9+ years of experience to ensure the compliance and safety of medical devices. I have a proven track record of successfully compiling and coordinating worldwide regulatory applications, such as 510(k) and EU MDR STED, to international agencies, such as FDA and EU MDR notified bodies, to enable product registrations.I also provide guidance to product development teams on key regulatory aspects, such as labelling, clinical evidence, risk management, biological safety, and sterilisation, to facilitate effective project planning and execution. Additionally, I support the customer regulatory requests, monitor the regulatory environment, and review the regulatory impact of changes in the organization.
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