About the role
AI summarisedSenior leader accountable for all quality and regulatory affairs for Roche’s Singapore affiliate, ensuring IVD products meet safety and compliance standards while interfacing with HSA and industry bodies.
BiopharmaOnsite
Key Responsibilities
- Drive business results by ensuring successful implementation of the mQMS
- Monitor internal global metrics and KPIs, coordinate local management reviews
- Take overall responsibility for regulatory submissions and product registrations across diverse portfolios including Core Lab, Molecular Lab, Point of Care, Pathology Lab, and Digital Solutions
- Serve as the primary external contact for the Health Sciences Authority (HSA) and industry bodies
- Oversee the complaint management system and drive the review of promotional materials to ensure full compliance with local laws
- Communicate significant quality or regulatory risks to Executive Management in a timely manner
- Serve as the Enterprise Risk Manager for the Singapore affiliate
- Ensure all products maintain valid licensing and lead the team to develop solutions ensuring daily work is completed without jeopardizing compliance
- Keep up with evolving traditional diagnostics and software/AI regulations, ensuring data privacy requirements (PDPA) are integrated into diagnostic data strategies
Requirements
- Hold a Bachelor’s degree in Biomedical Science or an equivalent field; a medical laboratory background is preferred
- Have at least 8 years of relevant work experience
- Possess recognized expertise in both Regulatory and Quality Affairs within the healthcare sector
- Have a proven track record of influencing external stakeholders and industry bodies
- Possess the executive presence required to represent Roche in high-stakes quality and regulatory discussions
- Demonstrate digital fluency, with experience navigating software/AI regulations and data privacy requirements (PDPA)
- Be a role model for agile leadership behaviors
- Able to troubleshoot complex technical issues as they arise
- Lead a high-performing team in a fast-paced, regulated environment