Regulatory Specialist, Medical Devices

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