Regulatory Specialist, Medical Devices
5 months ago
- 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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