Director of Quality & Regulatory Affairs

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 [email protected]

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