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