Director of Quality & Regulatory Affairs
Role summary
A surgical robotics company is seeking a senior Regulatory & Quality leader to guide global regulatory strategy and quality operations. This high-impact leadership role involves overseeing regulatory submissions (FDA, EU MDR, CE Mark), driving QMS development, and ensuring compliance with relevant standards. The position requires strong experience in MedTech regulatory affairs, leadership, and cross-functional collaboration, with a focus on surgical robotics and AI-enabled technologies. The role includes building and mentoring teams, contributing to long-term strategy, and supporting executive leadership.
Director of Regulatory Affairs & Quality – Surgical Robotics
Location: United States (USA)
We are partnering with an innovative surgical robotics company developing next-generation technologies designed to improve precision, workflow efficiency, and intraoperative decision-making within minimally invasive surgery.
Following continued growth and product development activity, the business is now seeking a senior Regulatory & Quality leader to help guide global regulatory strategy and quality operations across a highly innovative portfolio.
This is a high-impact leadership opportunity within a fast-growing MedTech environment, working closely with executive leadership, product development, clinical, and engineering teams.
Key Responsibilities:
• Lead global regulatory strategy across FDA, EU MDR, and international markets
• Oversee regulatory submissions including 510(k), De Novo, CE Mark, and software-related filings
• Drive quality management system (QMS) development and continuous improvement activities
• Support development and commercialisation of robotic and AI-enabled surgical technologies
• Partner closely with engineering and product teams throughout the product lifecycle
• Lead risk management, design control, and post-market surveillance activities
• Ensure compliance with FDA, ISO 13485, EU MDR, IEC 62304, and related standards
• Support audits, inspections, and interactions with regulatory authorities and notified bodies
• Build and mentor regulatory and quality teams as the organisation scales
• Contribute to long-term regulatory strategy and market expansion planning
• Support executive leadership on regulatory, compliance, and quality-related business initiatives
Qualifications:
• Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field
• Extensive experience within MedTech regulatory affairs and quality leadership roles
• Strong FDA submission experience including 510(k), De Novo, and software-driven products
• Deep understanding of EU MDR and international regulatory frameworks
• Exposure to surgical robotics, AI-enabled technologies, digital surgery, or minimally invasive devices strongly preferred
• Strong knowledge of design controls, risk management, and regulated product development processes
• Experience operating within high-growth, scale-up, or innovation-led MedTech environments preferred
• Proven ability to work cross-functionally across engineering, clinical, product, and executive teams
• Excellent leadership, communication, and strategic problem-solving skills
Either apply directly or reach out to Robbie Broomhead at robbie.broomhead@established-search.com
