Global Head of Quality & Regulatory Affairs

The Company is in search of a Global Head of Quality and Regulatory Affairs to lead and develop its global QA/RA function. This pivotal role involves shaping quality and regulatory strategy, ensuring product compliance, and driving both strategic and operational excellence. The successful candidate will be the primary quality and regulatory advisor to senior leadership, maintain the global Quality Management System, and champion a culture of quality throughout the organization. Key responsibilities include leading the QA/RA team, driving continuous improvement initiatives, and overseeing global product registrations and regulatory activities. The role demands a hands-on leader with a balanced background in quality and regulatory affairs, strong knowledge of international standards and regulations, and a proven track record in growth-oriented, transformation, or expansion environments. Candidates for this role at the company should have a degree in a relevant field and extensive experience in quality management and regulatory affairs within a regulated medical device environment. Essential experience includes a strong understanding of ISO 13485, ISO 9001, MDR, MDSAP, FDA 21 CFR Part 820, and other global regulations, as well as a proven ability to manage audits, inspections, and regulatory submissions. The ideal candidate will be a hands-on leader, adept at balancing strategic thinking with practical implementation, and capable of building and leading high-performing teams. An entrepreneurial mindset, strong communication skills, and the ability to work across multiple business functions are also key attributes. This is an exciting opportunity for a senior professional to make a significant impact on the company's quality and regulatory capabilities while supporting its ambitious growth and expansion plans.