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Head of Quality and Regulatory Strategy
2 months ago
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 Waters business growth and success.
Key Responsibilities
- Lead the development and implementation of global regulatory strategies to ensure compliance with FDA and international regulations.
- Manage and grow the teams, providing direction and leadership to ensure that 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.
- Champion product quality and the customer experience from development through manufacturing and into the post market phase.
- Work to develop annual budgets and manage the budget to ensure appropriate spend to meet financial requirements.
External Influence
- Interact with FDA and other global regulatory bodies to ensure timely and effective submissions.
- Establish, develop, and manage relationships with international regulatory agencies and standard bodies.
- Manage relationship with Contract Research Organizations to complete clinical studies and FDA submissions on schedule and budget.
- Maintain up-to-date knowledge of global regulatory requirements for all countries where product is registered for sale.
Qualifications
- Minimum of an Advanced degree (PhD, in a Life Science, MBA or equivalent).
- Proven extensive regulatory affairs experience with medical devices and IVD experience.
- Extensive and proven understanding of FDA and global regulations, including China, Europe, 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 a leading specialty measurement company that has pioneered 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.
