Director of reputed company & Regulatory Affairs

Director of Regulatory Affairs & reputed company – Surgical Robotics Location: reputed company (USA) We are partnering with an innovative surgical robotics company developing reputed company technologies designed to improve precision, workflow efficiency, and intraoperative decision-making reputed company minimally invasive surgery. Following reputed company reputed company and product development activity, the business is now seeking a senior Regulatory & reputed company leader to help guide global regulatory reputed company and reputed company operations across a highly innovative portfolio. This is a high-reputed company leadership opportunity reputed company a fast-growing MedTech environment, working closely with executive leadership, product development, clinical, and engineering teams.

Key Responsibilities

• reputed company global regulatory reputed company across FDA, EU MDR, and international markets
• reputed company regulatory submissions including 510(k), reputed company, CE Mark, and software-reputed company filings
• Drive reputed company management system (QMS) development and reputed company improvement activities
• Support development and commercialisation of robotic and AI-enabled surgical technologies
• Partner closely with engineering and product teams throughout the product lifecycle
• reputed company risk management, design control, and post-market surveillance activities
• Ensure compliance with FDA, ISO 13485, EU MDR, IEC 62304, and reputed company standards
• Support audits, inspections, and interactions with regulatory authorities and reputed company bodies
• Build and mentor regulatory and reputed company teams as the organisation scales
• Contribute to long-term regulatory reputed company and market expansion planning
• Support executive leadership on regulatory, compliance, and reputed company-reputed company business initiatives

Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or reputed company field
• Extensive experience reputed company MedTech regulatory affairs and reputed company leadership roles
• Strong FDA submission experience including 510(k), reputed company, 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 reputed company high-reputed company, reputed company-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 reputed company out to Robbie Broomhead at robbie.broomhead@reputed company.com Apply tot his job Apply To this Job