Head of Quality and Regulatory Affairs

About the role

Better Medicine is seeking a Head of Quality and Regulatory Affairs to lead the regulatory strategy for AI‑powered medical imaging devices in the EU and US. You will shape compliance frameworks for complex AI systems while driving product approvals.

Key responsibilities

• Develop and execute regulatory strategies for AI‑driven medical devices targeting EU and US markets.
• Engage with regulators such as the FDA and EU Notified Bodies to ensure timely approvals.
• Maintain up‑to‑date knowledge of evolving standards and guidelines for software as a medical device.
• Lead cross‑functional teams to align product development with regulatory requirements.
• Prepare and submit technical documentation, risk assessments, and clinical evidence.

Required profile

• Minimum 5 years of regulatory affairs experience, focusing on EU and FDA approvals.
• Proven track record of taking medical device products from development to market.
• Strong understanding of AI‑driven software in a medical context.
• Excellent communication, problem‑solving, and teamwork skills.
• Fluent in English with a detail‑oriented mindset.

Required skills

• IEC 62304
• ISO 14971

What we offer

• Fully remote work with flexible hours.
• Opportunity to influence the future of medical imaging technology.
• Collaborative international team across Estonia, UK, Ukraine and Spain.
• Professional growth in a fast‑moving AI healthcare environment.