Manager (Regulatory Affoutairs), Medical Technology Office (Contract)
Join SingHealth and play a pivotal role in advancing healthcare innovation across Singapore's largest public healthcare cluster. You’ll contribute to building a vibrant medtech ecosystem by supporting our strategic roadmap and helping translate groundbreaking innovations into real-world healthcare solutions.
We are seeking a Manager to coordinate and execute regulatory strategies. You’ll work closely with clinical teams, research departments, and regulatory authorities to ensure our innovation projects meet all compliance requirements whilst advancing through development phases towards successful market entry.
What You’ll Do:
You’ll support the development and implementation of regulatory strategies for healthcare innovations with a focus on medical devices, software, and diagnostics. Your role involves conducting gap analyses of current innovation projects against regulatory requirements, creating regulatory roadmaps aligned with product development timelines, and establishing frameworks for different innovation categories.You’ll manage document control repositories while complying with SingHealth policies, support adverse event investigations, and ensure post-market surveillance compliance.
Working with clinical teams, research and development departments, internal stakeholders, and external regulatory consultants, you’ll provide regulatory guidance throughout product development lifecycles and facilitate regulatory training across headquarters and institutions.You’ll handle day-to-day operational interactions with regulatory authorities, manage routine submissions and correspondence, and coordinate change control responses.
Additionally, you’ll monitor regulatory landscape changes, conduct competitor tracking activities, assess immediate impact of new regulations on hospital innovations, and design and implement the Regulatory Information Management Systems with digital workflows and standardised templates.Your administrative responsibilities include supporting marketing regulatory events, tracking key performance indicators, and liaising with stakeholders whilst ensuring compliance with organisational policies and maintaining proper documentation.
Job Requirements:
- Bachelor's Degree in Engineering, Bioengineering/Biomedical, Science, or related field with 6 years of relevant working experience in healthcare innovation
- Industry experience in regulatory submission with familiarity in ISO 13485, ISO 14971, IEC 62304, IEC 60601, and ISO 27001 and Health Sciences Authority (HSA) regulatory submissions
- Experience with medical device and Software as Medical Device (SaMD) regulatory requirements and maintenance plans
- Excellent project management abilities with strong attention to detail and organisational skills
- Strong network and understanding of medtech ecosystem and public healthcare landscape
- Strong communication and collaboration skills across cross-functional teams
- Knowledge in public healthcare innovation development roadmap and/or knowledge and experience in innovation translation would be advantageous