Senior Director - Quality, Regulatory and Clinical Affairs

Overview

Key leadership position for Regulatory and Clinical activities in support of the In Vitro Diagnostic Clinical business. This role leads a Global team of Regulatory Affairs professionals with Clinical Affairs activities.

The role will be responsible to work through multiple levels within the organization and external stakeholders to influence and drive Waters Regulatory & Clinical Affairs strategy to support Waters business growth and success.

Ensures all Regulatory and Clinical documentation is suitable for global registrations and maintained throughout the product life cycle.

This role will report directly to the Vice President, Clinical R&D and QRC

Responsibilities

Strategic Activities :

• Lead the Global Regulatory & Clinical Affairs function for Waters Corporation, with emphasis on global strategy for in vitro diagnostic clinical business activities
• Monitor trends and changes in regulations, standards and guidelines. Advise internal stakeholders on the potential impact to current and future strategy.

Ensure Waters Clinical systems and products meet applicable regulations, standards and guidance by the required application dates.

• Provide strategy and review for clinical study protocols, labeling, and integrated summary documents based on risk and all unique country requirements
• Proactively partner with R&D, Marketing, and other groups to 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 and targeted to meet desired risk as a business

Leads Regulatory and Clinical Affairs function :

• Manage the team, providing direction and leadership, ensuring that company objectives and regulatory requirements are met in the most efficient manner possible.
• Responsible for Worldwide programs, including Global Registration roadmap.
• Person responsible for Regulatory Compliance PRRC.
• Act as consultant to Clinical Business Unit management team on Regulatory and Clinical Affairs, with provision of solution based decision making
• Oversee the process of preparing product submissions and registrations to domestic and international regulatory bodies, managing the process from inception to approval and maintenance.
• Manage and conduct Regulatory Affairs activities including those related to New Product Development, Change Management, Post Market, potential Adverse events.
• Oversee set up and management of outside vendors such as License holders, In Country agents including importers, distributors and consultants.
• Participate in due diligence and integration activities of domestic or foreign acquisitions that have regulatory implications
• Works to develop annual budgets and manages the budget to ensure appropriate spend to meet financial requirements

External Influence :

• Interact with FDA and other global regulatory bodies plus registration authorities as required to ensure timely, effective submissions
• Manage relationship with international regulatory agencies and standard bodies, act as Waters representative providing input to application of existing regulations and proposed changes.
• Maintain up-to-date knowledge of global regulatory requirements for all countries where product is registered for sale through regulatory intelligence activities

Other :

Commitment to minimum 50% in-person / office, including average of 6 trips.

Qualifications

• Minimum of an Advanced degree (PhD, in a Life Science, MBA or equivalent
• Proven extensive +15yrs 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 7+ yrs managerial experience, including across multiple locations
• Experience in establishing, developing, and maintaining relationships with government authorities and regulatory agencies
• 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.
• Desired - Prior experience in a senior leadership role with overall responsibility for directing a Regulatory organization.
• Leadership skill in articulating a vision and moving an organization forward to achieve its goals and objectives
• Must have a strong understanding and practical application of IVD regulatory requirements.
• Strong ability to identify and analyse complex problems and recommend actions.
• Effective communication and influencing skills.
• Ability to mentor and develop individuals and teams

Company Description

Waters Corporation (NYSE : WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years.

With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries.

Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.

Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. 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. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization.

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. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.

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4 days ago