This Exclusive mandate seeks a highly experienced and motivated Global Head of Quality and Regulatory with direct leadership expertise and hands-on mentality to join a dynamic client in the medical device field. This leadership role is critical in ensuring our products meet the highest standards of quality and regulatory compliance across all markets. Key Responsibilities: Leadership and Strategy : Develop and implement global quality and regulatory strategies to ensure compliance with international standards and regulations. Regulatory Compliance : Oversee the preparation and submission of regulatory filings, ensuring timely approvals for new products and maintaining compliance for existing products. Quality Management : Lead the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards. Risk Management : Ensure robust risk management processes are in place, including risk assessments, CAPAs, and continuous improvement initiatives. Team Management : Lead and mentor a global team of quality and regulatory professionals, fostering a culture of excellence and continuous improvement. Stakeholder Collaboration : Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure quality and regulatory requirements are integrated into product development and lifecycle management. Audits and Inspections : Manage internal and external audits, including those conducted by regulatory bodies, and ensure timely resolution of any findings. Regulatory Intelligence : Stay abreast of global regulatory changes and trends, and proactively adjust strategies to maintain compliance and competitive advantage. Qualifications: Education : Advanced degree in a relevant field such as biomedical engineering, regulatory affairs, or a related discipline. Experience : Minimum of 8 years of experience in quality and regulatory roles within the medical device industry, with at least 5 years in a senior leadership position. Knowledge : In-depth knowledge of global regulatory requirements, including FDA, EMA, and other international regulatory bodies. Skills : Strong leadership and team management skills, excellent communication and interpersonal skills, and the ability to work effectively in a fast-paced, dynamic environment. Certifications : Relevant certifications such as RAC (Regulatory Affairs Certification) or CQE (Certified Quality Engineer) are highly desirable. Travel : Willingness to travel internationally as required. What We Offer: Innovative Environment : Be part of a leading medical device company that is at the forefront of innovation. Professional Growth : Opportunities for continuous learning and professional development. Competitive Compensation : Attractive salary and benefits package. Work-Life Balance : Flexible working hours and the possibility of remote work arrangements. Supportive Culture : A collaborative and inclusive work environment that values diversity and teamwork. Company Car Seniority level Not Applicable Employment type Full-time Job function Quality Assurance and Manufacturing Industries Medical Equipment Manufacturing #J-18808-Ljbffr