Regulatory Specialist, Medical Devices

Health Sciences Authority; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A government health regulatory agency is seeking motivated individuals to join as Regulatory Specialists for Medical Devices in Singapore. The role involves evaluating medical device applications for safety and quality, implementing regulatory frameworks, and educating industry stakeholders. Ideal candidates will have 3-5 years of experience in the medical technology sector, a degree in a relevant scientific discipline, and strong communication skills. This position offers a chance to contribute significantly to public health and safety.

Qualifications

• 3-5 years of relevant experience in the medical technology industry.
• Knowledge of medical software preferred.
• Ability to work independently and in teams.

Responsibilities

• Evaluate medical device applications for safety and quality.
• Implement regulatory framework and educate stakeholders.
• Conduct environmental scanning of the medical device market.
• Conduct market scanning for regulatory controls.

Skills

Knowledge of biomedical engineering

Communication skills

Interpersonal skills

Interpersonal skills

Education

Degree in Biomedical Engineering or related field

Job description

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 http://www.hsa.gov.sg/. For more updates on public health and safety matters, follow us on Twitter at www.twitter.com/HSAsg and LinkedIn at https://sg.linkedin.com/company/health-sciences-authority.