Deskripsi Pekerjaan
Join SingHealth Group and become a key driver in Singapore's healthcare innovation ecosystem. As Manager, Regulatory Affairs in our Medical Technology Office, you'll shape the future of medical device regulation while advancing patient care across our integrated healthcare network. This contract position offers the unique opportunity to work at the intersection of technology, compliance, and clinical practice in one of Asia's leading healthcare institutions.
You'll lead regulatory strategies for cutting-edge medical technologies, ensuring compliance with Singapore's HSA standards and international frameworks. The role demands strategic thinking to navigate complex regulatory landscapes while fostering collaboration between research, clinical, and commercial teams. If you're passionate about accelerating safe and effective medical innovations that impact thousands of lives, this is your chance to make a tangible difference in Singapore's largest public healthcare cluster.
Tanggung Jawab
- Develop and execute regulatory strategies for medical devices and healthcare technologies
- Manage submissions to regulatory authorities including HSA, FDA, and CE Mark
- Ensure compliance with global quality standards (ISO 13485, MDR, etc.)
- Lead cross-functional teams in product lifecycle compliance activities
- Monitor regulatory landscape changes and advise internal stakeholders
- Represent organization in regulatory audits and inspections
- Mentor junior regulatory affairs professionals
Kualifikasi
- Bachelor's degree in Life Sciences, Engineering, or related field; Master's preferred
- Minimum 7 years regulatory affairs experience in medical devices
- Deep knowledge of Singapore HSA regulations and international standards
- Professional certification (RAC, CQA) or equivalent
- Proven leadership experience managing regulatory teams
- Strong project management with complex product launches
- Excellent written communication for regulatory documentation