Regulatory Affairs Senior Director, Project Management Excellence

Job description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job DescriptionThe Senior Director of Regulatory Affairs, Project Management Excellence, reports to the VP of Regulatory Affairs of Regulatory Affairs Management, Enterprise Excellence. This role is responsible for providing project and program management leadership for various high-profile initiatives and business critical projects within BD Regulatory Affairs that may influence across multiple functions. The Senior Director of RA, Project Management Excellence, will also help to implement RA elements of BD Excellence and the Problem-Solving Process (PSP). This role is also responsible for RA governance and training and managing the centrally maintained Quality System Regulation (QSR) documentation, including policies, procedures and work instructions. This role will be responsible for identifying opportunities for optimization across the RA team, and partner to implement best practices and business solutions with the goal of ensuring BUs and Regions are able to complete their work effectively and efficiently. This role requires the ability to manage to a high level of project complexity and be able to influence the organization accordingly to ensure project success. The role requires a significant understanding of the Regulatory function and its associated activities. Job Responsibilities: (Primary Duties, Roles, and/or Authorities) Proven track record of leading project planning of complex regulatory elements and activities. Facilitation of global RA Kaizen events. Responsible for data analytics and reporting on metrics and key product indicators (KPIs) and activities across BDX RA. Lean manufacturing execution in BDX excellence principles – apply the problem-solving methodology to drive the Central RA team. Socialize digitalization and globalization solutions to ensure user needs are met and appropriate audiences are informed. Steer the Annual Strategic Review (ASR) process for regulatory affairs, ensuring alignment with enterprise goals and financial planning. Manage subsidiary-based and global projects/programs within the scope of Regulatory Affairs. Establish and lead program management activities associated with process improvements and compliance with regulations applicable to the BD product portfolio. Manage large-scale programs consisting of multiple active projects from project definition through program governance, monitoring and close out. This includes identifying and aligning resources on integration points. Provide guidance and support to strategic business partners to ensure best practices and project methodologies are followed. Adhere to BD established standards for project and program planning, execution and close out. Governance process owner (GPO) of BDX RA standard operating procedures, best practices, and ways of working. This includes working with various SMEs and business process owners throughout the organization to ensure content is accurate and complete. Education and Experience: Bachelor’s degree in science, engineering, or technology discipline required. Master’s degree in science, engineering, technology, or business administration required. Minimum of 15 years of Regulatory and/or Quality experience including project management within a medical device industry or similar regulated industry, with preference for experience in both a Quality and Regulatory role. Experience driving change management initiatives across an organization. Experience leading efforts in a dynamic highly regulated environment. Project Management Professional (PMP) or similar certification preferred. Regulatory Affairs Certification (RAC) preferred. Certification in the Problem-Solving Process (PSP 101) and Kaizen initiatives preferred. Knowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs. Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions. Decision Quality: Accurately assesses risk and clarifies ambiguous situations to make good decisions, developing alternatives with clearly documented consequences for each possible course of action. Communication Skills: Skilled facilitator for small and large groups and organizations, adapting content and style to engage audience, and able to articulately respond to impromptu comments and questions. Action Oriented: Demonstrates a significant bias for action to execute key objectives, while actively seeking other opportunities to contribute. Courage & Independence: Seeks out and selects stimulating work with challenges, increasing scope and responsibilities. Composure: Responds constructively in stressful situations and effectively calms others while taking action to resolve the root cause of the situation causing stress. Flexibility: Adapts plans to changing priorities, modeling and practicing key principles of change management. Process Effectiveness: Independently identifies the most efficient way to simplify and implement complex processes. Process and Service Acumen: Thorough understanding of service-related processes and service engineering with ability to independently influence organizational direction. Organizational Agility: Is cognizant of organizational culture in a matrixed environment and appropriately adjusts personal style to be effective. Builds numerous and beneficial relationships through personal networks, inside and outside the organization. Influencing Others: Leverages internal or external experts or third parties to influence others towards an intended course of action. Experienced at using multiple chains of influence to achieve broad organizational acceptance Dealing with Ambiguity: Anticipates the organizational impact of change, rising to the challenge, applying ingenuity, while accepting risk and uncertainty as normal. Building Effective Teams: Builds mission-driven, cohesive teams of people, sharing team wins and successes throughout the organization to instill team member value and appreciation. Physical Demands: (if applicable) When work is performed in an office environment the position requires the ability to operate standard office equipment and keyboards. Must have the ability to stand, walk and sit; talk or hear, both in person and by telephone; use hands to finger, handle or feel objects or controls; reach with hands and arms. Ability to travel US and OUS travel ~25%. Work Environment: (if applicable) Position is currently categorized as a hybrid role. At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role: Annual Bonus Potential Discretionary LTI Bonus Potential reimbursement of vehicle use/mileage Potential reimbursement of phone use Health and Well-being Benefits Medical coverage Health Savings Accounts Flexible Spending Accounts Dental coverage Vision coverage Hospital Care Insurance Critical Illness Insurance Accidental Injury Insurance Life and AD&D insurance Short-term disability coverage Long-term disability insurance