Regulatory Affairs Specialist

Support a medical imaging AI startup through certification

We're looking for a regulatory professional to support our medical imaging AI software through certification processes. You'll collaborate with clinical, engineering, and leadership teams to ensure our products meet safety and compliance standards as we move toward commercial pilots.

Key Responsibilities

• Support FDA and EU MDR certification pathways and regulatory strategy
• Develop and enhance quality management and compliance procedures
• Create technical, regulatory, and clinical documentation for medical software
• Manage risk assessment, clinical evaluation, usability, and post-market activities
• Coordinate with auditors, notified bodies, and certification partners
• Partner with engineering and clinical teams on compliant development

Requirements

• 4+ years of experience in Regulatory Affairs, Quality Assurance, or related roles within healthcare, medical technology, or regulated software environments
• FDA 510(k) or EU MDR pathway experience
• Background supporting audits, certification, and quality management processes
• Detail-oriented documentation management abilities
• Strong communication and organizational competencies
• Professional English proficiency

Preferred Qualifications

• Scientific, healthcare, engineering, or technical degree
• Knowledge of medical device standards (ISO 13485, IEC 62304, ISO 14971)
• Familiarity with clinical studies and statistical analysis
• Startup or growth-stage healthcare technology experience

Why Join

• Be part of an innovative early-stage startup with a mission to improve healthcare
• Shape the regulatory strategy of a clinical AI product from the ground up — not inherit someone else's decisions
• Competitive salary and career growth opportunities
• Collaborate closely with engineering and clinical leadership — no regulatory function siloed from the rest of the team
• A collaborative and flexible work environment