Regulatory Specialist, Medical Devices Health Sciences Authority | Enforcement Fixed Terms Clos[...]
2 weeks ago
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 within target timelines. Implementation of the medical device regulatory framework, including effective communication of the regulatory policy to industry and other stakeholders. Respond to queries, feedback and provide clarifications to educate industry stakeholders on regulatory requirements and enhance regulatory compliance. Conduct periodic environmental scanning of the medical device market to prepare for appropriate regulatory controls for novel innovative medical devices. What we are looking for: Possess knowledge and experience in related scientific disciplines, e.g., Biomedical Engineering, Biomedical Sciences, Medical Technology, Pharmacy, Public Health or any related biomedical/ clinical specialties. Preferably 3-5 years of relevant experience in the medical technology industry, including medical software. Past research experience in R&D, biological sciences, bioengineering and biomedical areas will be an advantage but not essential. Good communication and interpersonal skills. Able to work independently, as well as in a team. Able to work effectively with people from different backgrounds Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified. About Health Sciences Authority The Health Sciences Authority (HSA) applies medical, pharmaceutical and scientific expertise through its three professional groups, Health Products Regulation, Blood Services and Applied Sciences, to protect and advance national health and safety. HSA is a multidisciplinary authority. It serves as the national regulator for health products, ensuring they are wisely regulated to meet standards of safety, quality and efficacy. As the national blood service, it is responsible for providing a safe and adequate blood supply. It also applies specialised scientific, forensic, investigative and analytical capabilities in serving the administration of justice. For more details, visit For more updates on public health and safety matters, follow us on Twitter at and LinkedIn at #J-18808-Ljbffr
-
Singapore Health Sciences Authority Full time**What the role is** - Work Location: Helios, 11 Biopolis Way, Singapore 138667 Responsibilities - Initiate the development of sound regulatory policy and deep scientific expertise, and to provide regulatory and scientific guidance in the field of medical devices - Contribute and manage the team in scientific evaluation of medical devices and providing...
-
Singapore Health Sciences Authority Full timeSenior Enforcement Inspector/Enforcement Specialist, Enforcement Branch What the role is As a Senior Enforcement Inspector / Enforcement Specialist, you will be part of a team to undertake a range of challenging enforcement activities to safeguard public health. What you will be working on Provide effective management and leadership to investigation officers...
-
Singapore Health Sciences Authority Full time**What the role is** - As a Senior Regulatory Inspector/Regulatory Inspector, you will be part of a team to undertake a range of challenging enforcement activities to safeguard public health Work Location: Helios, 11 Biopolis Way, Singapore 138667 Responsibilities As a Senior Regulatory Inspector/Regulatory Inspector, you will be part of a team to undertake...
-
Senior Regulatory Inspector
2 weeks ago
Singapore Health Sciences Authority Full time**What the role is** - As a Senior Regulatory Inspector/Technical Specialist, you will be part of a team to undertake a range of challenging enforcement activities to safeguard public health. - Provide effective management and leadership to investigation officers - Plan and oversee inspections and routine enforcement checks - Conduct raids, gather...
-
Singapore HSA Health Sciences Authority Full timeAs an Enforcement Inspector, you will be part of a team to undertake a range of challenging enforcement activities to safeguard public health. [What the role is] As an Enforcement Inspector, you will be part of a team to undertake a range of challenging enforcement activities to safeguard public health. [What you will be working on] - Conduct raids,...
-
Senior/Regulatory Specialist
2 weeks ago
Singapore Monetary Authority of Singapore Full timeWhat the role is Clinical evaluation of therapeutic product registration submissions What you will be working on Evaluate the clinical data of therapeutic product applications for product registration to assure the safety and efficacy of medicines supplied in Singapore Handle enquiries and requests from applicants, industry stakeholders and members of public...
-
Singapore ALCOTECH PTE. LTD. Full timeA specialist regulatory company in Singapore is looking for a Regulatory Affairs Specialist. The role includes preparing medical device registration dossiers for HSA and ensuring compliance with regulations. Ideal candidates have 2–5 years of regulatory affairs experience and strong knowledge of Singapore's medical device regulations. The job offers a...
-
Senior/ Regulatory Specialist
3 days ago
Singapore Health Sciences Authority Full time**What the role is** - Post-market vigilance and safety monitoring to ensure the continued safety and quality of marketed health product, including instituting timely and appropriate regulatory actions to ensure the safe and appropriate use of health products. - Develop and implement Good Pharmacovigilance Practice (GVP) compliance framework and conduct GVP...
-
Regulatory Affairs Specialist
1 week ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full time**THE OPPORTUNITY**: An esteemed **Medical Devices Company **is currently seeking a highly capable **Regulatory Affairs Specialist **to join their team. The successful incumbent will be tasked with the development and implementation of efficient regulatory strategies and processes, ensuring timely product registration, life cycle management, and post-market...
-
Regulatory Consultant
3 days ago
Singapore Health Sciences Authority Full time**What the role is** - Post-market vigilance and safety monitoring to ensure the continued safety and quality of marketed health product, including instituting timely and appropriate regulatory actions to ensure the safe and appropriate use of health products. - Review and manage product defect issues and product recalls relating to medicines and vaccines,...
