The Director, Global Regulatory Operations, Systems manages drives how the regulatory function brings together technology, processes and resources to enable strategic objectives and underpin Regulatory core capabilities for a medical device company. Develops and implements the Regulatory System Strategy in line with broader organization objectives. This role leads the oversight and governance of Regulatory systems, business processes and compliant usage to ensure that the objectives of the regulatory information strategy are met. The Director of Systems will partner with individual system owners within Regulatory to ensure the overall strategy for RA is met. This role will provide the holistic strategy of Regulatory Systems integration, and partner with IT & Business functions as well as with vendor(s) to influence HA and industry innovation.
Responsible for analyzing Regulatory IT/technology industry trends and driving best practices across Regulatory and cross functional interfaces.
Responsible for developing & evolving the regulatory system strategy in line with regulatory affairs & affected stakeholders, including industry and Health Authority perspectives, to ensure robust future proof processes and systems.
Oversees new system implementation for the Regulatory function and partners with cross functional groups as applicable
Accountable for overseeing regulatory information quality, reporting and analytics to monitor quality and maximize the use of regulatory information. Includes interface data that is required between different cross functional systems and drives the integration of data and processes
Responsible for developing and implementing a strategy to ensure oversight of system compliance, business value and efficiency in the management and delivery of regulatory system services, leveraging appropriate vendor partnerships.
Represent BD at HA/Industry body meetings for regulatory information strategy and influence applicable policies and adoptions of data standards and regulatory technological advancements
Researches forthcoming regulatory guidance revisions and analyses subsequent impacts to internal processes & technology (e.g. EU MDR/IVDR/UDI). Communicates impacts to wider business functions, and drives execution in collaboration with stakeholders.
Effectively communicates project status, issues, schedule and accomplishments to regulatory affairs and stakeholder groups, as needed. Ensures regulatory information strategy is communicated and understood by broader cross functional teams.
Manage team with various levels of experience to ensure both company goals and individual growth opportunities are met
Proactively make changes as needed to support changing priorities
Manage vendor relationship, as needed, related to regulatory operations activities
Support compliance with worldwide submission regulations and guidelines by maintaining awareness and continually expanding knowledge of pertinent laws, regulations, guidance and practices.
Essential Job Functions:
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
This role will focus on medical devices but knowledge of pharmaceutical technology and systems is an advantage. Implementation, validation, and integration of Regulatory systems within existing business processes, including:
Electronic Document Management System (EDMS)
Submissions Publishing Systems
Submissions Management Systems
Advertising and Promotions tools
Master Product Data
Regulatory Information Mgmt
Business requirements gathering skills Project management and business process improvement skills Working knowledge of pharmaceutical submissions Experience supporting business users in a Regulatory environment
Broad knowledge of current technologies used within an IT infrastructure, SDLC, computer systems, database and software development architecture, and the ability to apply technical knowledge to support the business needs
Develops production support model for the post-release of Regulatory systems Manages Business Administration activities for Regulatory systems
Internal Number: R-306020
About Becton Dickinson
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com.