Senior Director of Quality, Regulatory and Clinical Affairs

Overview

Key leadership position for Quality, Regulatory and Clinical activities in support of the In Vitro Diagnostic Clinical business. The role will be responsible to work through multiple levels within the organization and external stakeholders to influence and drive Waters Quality, Regulatory & Clinical Affairs strategy to support Waters business growth and success of the Clinical organization. This role will be part of Waters Clinical Leadership Team and report directly to the Vice President, Clinical R&D and QRC.

Responsibilities

Strategic Activities:

• Lead the Global Design Quality Assurance, Regulatory & Clinical Affairs functions for Waters Clinical Business Unit, with emphasis on global strategy for in vitro diagnostic clinical business activities.
• Lead regulatory strategy planning and execution for all key clinical programs globally.
• 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, labelling, and integrated summary documents based on risk and all unique country requirements.
• Proactively partner with R&D, Product Management, Marketing, and other functions 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.

• Manage and grow the teams, providing direction and leadership, ensuring that company objectives and regulatory requirements are met in the most efficient manner possible.
• 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 acquisitions that have regulatory implications.
• Lead and manage Clinical Design Quality Assurance, provide solution-based decision making, and drive continuous improvement.
• Act as specialist in relation to design and development ensuring conformance and up-to-date information on applicable regulatory requirements including as appropriate: ISO 9001; ISO 13485; 21 CFR parts 11 and 820, ISO 62304, ISO 62366, ISO 14971.
• Champion product quality and the customer experience from development through manufacturing and into the post market phase.
• Works to develop annual budgets and manages the budget to ensure appropriate spend to meet financial requirements.

• Interact with FDA and other global regulatory bodies plus registration authorities as required to ensure timely, effective submissions.
• Establish, develop, and manage relationships with international regulatory agencies and standard bodies, act as Waters representative providing input to application of existing regulations and proposed changes.
• 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 through regulatory intelligence activities.

• Minimum of an Advanced degree (PhD, M.S.) 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.
• Must have good business acumen and good 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.
• 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.
• Strong ability to identify and analyse complex problems and recommend actions.
• Effective communication and influencing skills.
• Ability to mentor and develop individuals and teams.