The Company is in search of a VP Global Quality and Regulatory to join their team. The successful candidate will be a strategic business partner, driving the quality and regulatory strategy to ensure compliance with global standards for class I, II, and III productions. This role is pivotal in managing the global quality and regulatory functions, with a focus on manufacturing, services, and 3rd party products. The VP will be responsible for aligning the quality strategy with the business area strategy, owning the global quality and regulatory budget, and driving quality as a competitive advantage. They will also be champions of a global culture of quality, accountability, and continuous improvement, and will lead the deployment of Lean/Six Sigma or equivalent methodologies across the organization. Candidates for this role should have a minimum of 15 years' experience in a global organization within a regulatory or quality function, with a technical degree and a preference for a Master's. Core competencies include compliance with various international standards and regulations, and knowledge of FDA and ISO standards for medical devices. The VP will be expected to have a deep understanding of quality systems regulations and to be a subject matter expert in US FDA regulations. Responsibilities also include overseeing product registrations, managing the vigilance/medical device reporting system, and ensuring compliance with all applicable regulations. The role requires the ability to work in a fast-paced, global environment and may involve travel as needed.

Hiring Company

Trelleborg Group