Assistant Director (Regulatory Affairs) Medical Technology Office (Contract)

Join SingHealth and play a pivotal role in transforming healthcare innovation across Singapore's largest public healthcare cluster. You will lead our regulatory strategy as we advance towards product ownership and work at the intersection of cutting-edge medical technology and regulatory excellence to bring life-changing innovations to patients.

We are seeking an Assistant Director to develop and execute comprehensive regulatory strategies that accelerate our innovation pipeline from concept to market. You will provide strategic leadership for our regulatory affairs function, build relationships with health authorities and stakeholders whilst establishing SingHealth as a thought leader in healthcare regulatory innovation.

What You Will Do:

You will develop and implement strategic regulatory frameworks for innovation projects across multiple jurisdictions, providing executive-level oversight to ensure alignment with SingHealth's product ownership objectives. Your role involves leading high-level negotiations and strategic discussions with health authorities, managing relationships with senior executives across institutions and business partners, and representing the cluster at industry regulatory forums and advisory committees.

You'll oversee comprehensive regulatory portfolio management for innovation projects, coordinate submissions and post-approval activities whilst ensuring maintenance of all product registrations. Additionally, you will lead and develop the regulatory affairs department, establish departmental processes and provide mentorship to team members, whilst driving regulatory intelligence activities to anticipate and influence regulatory developments affecting our innovations.

You'll also contribute to quality assurance initiatives, work with stakeholders to establish regulatory document control repositories and support adverse event investigations to ensure post-market surveillance compliance.

Job Requirements:

• Bachelor's Degree preferably in Life Sciences, Engineering, Computer Science or Business with 10 years of relevant working experience in healthcare innovation
• Industry experience in regulatory submissions with familiarity in ISO 13485, ISO 14971, IEC 62304, IEC 60601, and ISO 27001 standards and Health Sciences Authority (HSA) regulatory submissions
• Proven track record in regulatory registration of medical devices and medical-use software and managing international certification projects and engaging with health authorities
• Experience with medical device and Software as Medical Device (SaMD) regulatory requirements and maintenance plans
• Excellent project management abilities and organisational skills with strong attention to detail
• Strong network and understanding of medtech ecosystem and public healthcare landscape
• Strong leadership attributes with excellent communication and collaboration skills across cross-functional teams