Regulatory Specialist, Medical Devices

Singapore, Singapore

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We are looking for highly motivated individuals with a strong desire to protect public health and safety to join us as Regulatory Specialists.

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.

Job Requirements

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

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