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Senior Director of Quality and Regulatory Affairs

2 months ago

Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time

Job Summary

The Senior Director of Quality and Regulatory Affairs will lead the global design quality assurance, regulatory, and clinical affairs functions for Waters Clinical Business Unit. This role will be responsible for developing and implementing regulatory and clinical strategies to support business growth and success.

Key Responsibilities

  • Lead the development and implementation of global regulatory strategies for clinical programs.
  • Monitor trends and changes in regulations, standards, and guidelines, and advise internal stakeholders on potential impacts.
  • Ensure Waters Clinical systems and products meet applicable regulations, standards, and guidance.
  • Provide regulatory advice and guidance on meeting necessary requirements to place products on the market globally.
  • Develop and implement regulatory and clinical policies and procedures aligned with the overall company strategy.
  • Manage and grow the teams, providing direction and leadership to ensure company objectives and regulatory requirements are met.
  • Oversee the process of preparing product submissions and registrations to domestic and international regulatory bodies.
  • Manage and conduct Regulatory Affairs activities, including those related to New Product Development, Change Management, Post Market, and potential Adverse events.
  • Participate in due diligence and integration activities of acquisitions that have regulatory implications.
  • Lead and manage Clinical Design Quality Assurance, provide solution-based decision making, and drive continuous improvement.
  • Act as a specialist in relation to design and development, ensuring conformance and up-to-date information on applicable regulatory requirements.

Requirements

  • Minimum of an Advanced degree (PhD, in a Life Science, MBA or equivalent)
  • Proven extensive regulatory affairs experience with medical devices, IVD experience essential
  • 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 to meet business needs in partnership with other key stakeholders and functions
  • Proven experience with the development of global regulatory strategies
  • Proven knowledge of design and execution of processes compliant to ISO 9001, ISO 13485, ISO 14971, ISO 62304, 21 CFR 820, IVDR
  • Experience with Design Assurance management for Class I/II/III medical devices/systems and/or in-vitro diagnostics experience

About Waters Corporation

Waters Corporation is the world's leading specialty measurement company, pioneering chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With a global team of over 7,000 employees, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries.

At Waters, we strive to be better, learn and improve every day in everything we do. We're the problem solvers and innovators that aren't afraid to take risks to transform the world of human health and well-being. We're all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.

Diversity and inclusion are fundamental to our core values at Waters Corporation. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers, and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer.