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Singapore Health Sciences Authority Full time $80,000 - $120,000 per yearWhat the role is [What the role is] This position serves to support the Audits Branch (AB) in implementing the regulatory inspection and licensing regime, policies and initiatives governing the full spectrum of dealers across various health product categories in Singapore so as to meet HSA's national objective of ensuring that these health products...
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Singapore Health Sciences Authority Full time(What the role is)We are looking for highly motivated individuals with a strong desire to protect public health and safety to join us as Regulatory Specialists of Medical Devices.(What you will be working on)Screen and evaluate medical device pre/post-marketing applications to ascertain that medical devices meet safety, quality and performance requirements...
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Regulatory Specialist, Medical Devices
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Singapore Health Sciences Authority Full time(What the role is)We are looking for highly motivated individuals with a strong desire to protect public health and safety to join us as Regulatory Specialists of Medical Devices. (What you will be working on) Screen and evaluate medical device pre/post-marketing applications to ascertain that medical devices meet safety, quality and performance...
Health Sciences Authority Jobs Healthcare Regulatory Specialist Position Open
2 weeks ago
The role is designed to support the implementation of regulatory inspection and licensing regimes across various health product categories in Singapore. The main objective is to ensure that these products meet required standards of quality, safety, and efficacy to safeguard public health and safety.
Key responsibilities include leading or conducting local/overseas regulatory inspections and licensing of manufacturers and dealers of health products and pharmacies. This involves ensuring they conform to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and relevant quality system standards.
Additionally, the position entails reviewing and developing technical standards, industry guidelines, and internal good practice guidance on GMP inspections. It also involves implementing the Quality Management System (QMS) in accordance with international standards like PIC/S, ISO 9001, and WHO ML4 & WLA.
The successful candidate will collaborate with international colleagues to facilitate technical liaison with other regulatory authorities and relevant bodies in the field of GMP inspection.
This role requires strong knowledge/experience in pharmacy, life sciences, pharmacology, chemistry, chemical engineering, biochemistry, biotechnology, microbiology, genetic or tissue engineering. A good understanding of international regulatory landscapes and developments in biopharmaceutical or cell, tissue, and gene therapy products is essential.
Familiarity with computer software, effective communication skills, and ability to work as part of a multidisciplinary team are also necessary.
This is an exciting opportunity for those passionate about GMP inspection work and committed to advancing national health and safety.
