About Us
Gray Matter Solutionsis a digital health company at the forefront of neuroscience-based tools for the early detection and monitoring of neurodegenerative diseases, including Alzheimer's Disease, Vascular Dementia, and Parkinson's Disease. Our mission is to empower healthcare professionals with scalable, validated digital solutions that bridge the gap between research and real-world impact. Through our cutting-edge platforms, we aim to transform patient care and reduce the societal and economic burden of neurodegeneration.
We currently have ISO13485 certification and a Class A software medical device on the Singapore Market, and actively expanding to ASEAN and global markets.
About the Role
We are seeking a Regulatory Affairs Intern to support regulatory strategy and execution for our digital health products. This role offers hands-on exposure to regulatory processes across multiple jurisdictions and close collaboration with clinical, product, and leadership teams.
Key Responsibilities- Support regulatory strategy and documentation for digital health / SaMD products
- (HSA Singapore, EU MDR / CE-marking, FDA SaMD pathways)
- Assist in preparing and organizing technical and regulatory documentation, including:
- Intended use statements
- Risk classification and risk management files
- Labeling and clinical claims
- Contribute to clinical evaluation and validation documentation
- Support quality management system (QMS) activities (e.g. ISO 13485-aligned documentation)
- Track regulatory requirements, timelines, and submission status
- Conduct regulatory landscape and precedent research for comparable digital health products
- Support coordination between regulatory, clinical, and product teams during rollout
Candidate Profile- Background in biomedical engineering, life sciences, pharmacy, public health, regulatory science, or related fields
- Strong interest in medical devices, digital health, or AI in healthcare
- Highly detail-oriented with strong written and organizational skills
- Comfortable reviewing guidelines, standards, and regulatory frameworks
- Able to work independently and manage multiple tasks in a fast-moving environment
- Bonus (not required):
- Exposure to SaMD, HSA, FDA, or EU MDR processes
- Experience in startups, clinical research, or health tech
- Familiarity with documentation tools (Notion, Google Docs, Excel)
What You'll Gain- Practical exposure to end-to-end regulatory processes in digital health
- Experience working with clinically validated, real-world healthcare products
- Close mentorship from senior clinical and product leadership
- Insight into how regulatory strategy supports commercial deployment and scale
- Opportunity for extension into a longer-term or full-time role, subject to performance and company needs
How to ApplyPlease submit:
- CV
- A brief statement (35 sentences) describing your interest in digital health and regulatory affairs
Email: [Confidential Information]
Subject line: Regulatory Affairs Intern Gray Matter Solutions
