Regulatory Specialist, Medical Devices

Health Sciences Authority; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A government health agency in Singapore is seeking a Regulatory Specialist for Medical Devices. This role involves ensuring compliance with regulations, evaluating medical device applications, and providing education to industry stakeholders. Candidates should have a relevant degree and 3-5 years of experience in the medical technology industry. Strong communication skills are essential for this position.

Qualifications

• Knowledge and experience in Biomedical Engineering, Biomedical Sciences, or related fields.
• 3-5 years in the medical technology industry, preferably.
• Ability to work effectively with diverse teams.

Responsibilities

• Evaluate medical device applications to ensure safety and compliance.
• Implement the medical device regulatory framework.
• Respond to stakeholder inquiries regarding regulations.

Skills

Knowledge in Biomedical Engineering

Good communication skills

Interpersonal skills

Education

Relevant scientific disciplines degree

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.