About Ocumetra
At Ocumetra, we are transforming the landscape of paediatric eye care with innovative, data-driven tools for myopia management. Our clinical decision support software empowers eye care professionals with actionable insights to improve vision outcomes in children. As we continue our growth journey, we’re looking for a dedicated Regulatory Affairs Officer to lead key regulatory initiatives and ensure compliance with global standards.
The Role
We are seeking a proactive and detail-oriented Regulatory Affairs Officer to support and strengthen our regulatory infrastructure. This individual will play a critical role in maintaining and enhancing our Information Security Management System (ISMS) and Quality Management System (QMS) and will take the lead in preparing our FDA submission for our software as a medical device (SaMD) product.
This is a strategic position with significant opportunity for growth, including expanding regulatory submissions into new global markets.
Essential Functions & Responsibilities
ISMS & QMS Management
Maintain and improve Ocumetra’s ISMS (ISO/IEC 27001) and QMS (ISO 13485:2016)
Ensure ongoing compliance through internal and external audits, risk assessments, CAPAs, and document control
Collaborate cross-functionally to embed quality and security processes into daily operations
Regulatory Submissions
Lead the planning, coordination, and execution of the FDA De Novo or 510(k) submission for our SaMD product
Prepare and manage regulatory documentation, including pre-submissions, regulatory strategies, and technical files
Liaise with consultants, regulatory bodies, and internal stakeholders to ensure timely and accurate submissions
Compliance & Market Expansion
Monitor global regulatory changes and support strategies for future market expansion (e.g., CE Marking under MDR, Health Canada, TGA)
Ensure compliance with applicable medical device software regulations (e.g., FDA 21 CFR Part 820, IEC 62304, ISO 14971)
Global Regulatory Strategy
Develop and drive a global regulatory roadmap.
Evaluate, prioritize, and plan market expansion opportunities in alignment with business goals.
Required Skills
Bachelor’s or Master’s degree in a relevant field (e.g., Regulatory Affairs, Biomedical Engineering, Life Sciences, Quality Management)
Minimum 2–4 years of experience in regulatory affairs, preferably with medical device software or digital health products
Familiarity with ISO 13485, ISO/IEC 27001, IEC 62304, and other relevant standards
Strong documentation and organizational skills with a keen attention to detail
Excellent communication and stakeholder management abilities
Desirable Skills
Hands-on experience with FDA submissions (De Novo or 510(k))
Experience with EU MDR or international regulatory submissions
Working knowledge of cybersecurity frameworks in the context of health software
What We Offer
· Opportunity to be part of an innovative health tech company improving global eye health outcomes
· A collaborative, mission-driven team environment
· Flexible remote work options
· Career development opportunities in regulatory leadership as we grow globally
Join Us
If you’re passionate about regulatory science and want to shape the future of digital eye care, we’d love to hear from you. Apply now and help us power the change from vision correction to myopia prevention and management.