Clinical Informatics Regulatory Lead

Job Summary

Job Title Clinical Informatics Regulatory Lead

In this role you will lead global regulatory strategy for a portfolio of AI-enabled healthcare software, Digital & Computational Pathology, Disease Management Systems, and clinical informatics solutions.

As a member of the Clinical Informatics leadership team, you will drive regulatory strategy, market access, lifecycle compliance, and regulatory excellence across global markets while enabling innovation in software, cloud-connected, and AI-powered technologies.

Your role

• Lead global Regulatory Affairs strategy and execution across the Clinical Informatics portfolio.
• Drive regulatory pathways, submissions, registrations, and market access activities worldwide.
• Partner with R&D, Quality, Clinical, Product Management, Cybersecurity, and Commercial teams on new products, software releases, AI/ML capabilities, and market expansions.
• Advise senior leaders on regulatory risk, timelines, and business decisions.
• Represent the company with FDA, notified bodies, competent authorities, and regulators globally.
• Build and develop a high-performing Regulatory Affairs organization.

You're the right fit if you have

• Bachelors / Masters Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
• Strong knowledge of FDA, EU MDR/IVDR, ISO 13485, ISO 14971, MDSAP, and global regulatory frameworks.
• 8+ years of Regulatory Affairs experience with significant experience in medical devices and/or IVDs.
• Experience with SaMD, AI/ML-enabled products, cloud-connected solutions, cybersecurity, and interoperability is mandatory.
• Proven leadership of global regulatory strategies and complex product portfolios.
• Experience in clinical informatics, digital pathology, radiology, oncology, urology, or diagnostic imaging preferred.
• Strong people leadership, executive presence, and stakeholder influence skills.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.