Senior Director of Quality and Regulatory Affairs

2 months ago


Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time
Job Summary

We are seeking a highly experienced and skilled Senior Director of Quality, Regulatory and Clinical Affairs to lead our Global Design Quality Assurance, Regulatory & Clinical Affairs functions for our Clinical Business Unit. This role will be responsible for developing and implementing global regulatory strategies, managing regulatory affairs activities, and ensuring compliance with applicable regulations and standards.

Key Responsibilities
  • Strategic Leadership: Develop and implement global regulatory strategies to ensure compliance with applicable regulations and standards.
  • Regulatory Affairs Management: Manage and conduct regulatory affairs activities, including those related to new product development, change management, post-market activities, and potential adverse events.
  • Quality Assurance: Lead and manage Clinical Design Quality Assurance, provide solution-based decision making, and drive continuous improvement.
  • Team Management: Manage and grow the teams, providing direction and leadership, ensuring that company objectives and regulatory requirements are met in the most efficient manner possible.
  • External Influence: Interact with regulatory bodies, registration authorities, and other external stakeholders to ensure timely and effective submissions.
Requirements
  • Education: Minimum of an Advanced degree (PhD, in a Life Science, MBA or equivalent)
  • Experience: Proven extensive regulatory affairs experience with medical devices, IVD experience essential
  • Skills: Extensive and proven understanding of FDA and global regulations, including China, Europe (IVDR), India, and Brazil; significant managerial experience, including across multiple locations; good business acumen and collaboration skills


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