Bd
Medical Technology
RegulatoryAffairsSeniorManager,Digitalization
Neural analysis suggests this role is
optimal for Senior candidates.
“Regulatory Affairs Senior Manager, Digitalization at Bd. Skills: Regulatory Affairs, Digitalization, Regulatory Information Management, System implementation. Improve Regulatory Affairs digital platform. Manage regulatory and product information”
Industry & Context.
Problem Solving; Analytical Skills; Professional Judgement
What They're Looking For.
Must Have
Bachelor's degree in science, engineering, or technology discipline, Minimum of 5 years in Medical Device industry, Minimum 5 years working with IT to launch and maintain RA Systems following GxP, Computer Systems Validation (CSV) and Software Development Lifecycle (SDLC) standards, Minimum 10 years of experience in business operations management
Nice to Have
Master's degree in business, management, or technology related field, Minimum of 5 years in Medical Device industry, with roles in Regulatory Affairs and/or Quality Systems
What You'll Do.
Improve Regulatory Affairs digital platform
Manage regulatory and product information
Manage submission management
Define and evolve BD’s RA digital strategy
Recommend strategic opportunities and initiatives
Identify global RA programs
Prioritize global RA programs
Formalize global RA programs
Analyze internal performance data
Analyze external benchmarks
Assess emerging digital technologies
Assess technical trends
Assess impact and value
Align with Global Regulatory Strategy
Define Digital RA strategy
Drive Digital RA strategy
Ensure alignment with enterprise priorities
Integrate across Segments
Oversee prioritization of digital regulatory initiatives
Oversee execution of digital regulatory initiatives
Ensure timely delivery of initiatives
Ensure measurable outcomes of initiatives
Ensure stakeholder alignment for initiatives
Co-create initiatives with TGS
Implement initiatives with TGS
Implement digital solutions
Co-create regulatory function goals
Lead initiatives to achieve measurable outcomes
Collaborate with central teams
Collaborate with business units
Collaborate with regional partners
Implement flexible technology
Implement efficient technology
Implement scalable technology
Leverage digital tools
Enhance system flexibility
Enhance operational efficiency
Enhance global harmonization
Lead application test planning
Lead application test execution
Execute PQ/Use Acceptance Testing
Review SDLC documents
Participate in key meetings
Ensure user requirements are understood
Ensure business process is understood
Ensure design is understood
Act as business test lead
Assist in regression testing
Provide CSV/Validation centric input
Manage the RIMSYS team
Direct preparation of RIM budgets
Direct preparation of RIMSYS budgets
Maintain operating costs within budget constraints
Manage project budgets
How You'll Work.
Team & Collaboration
Cross-functional teams; Central teams; Business Unit teams; Regional teams; Senior leadership; Regulatory Leadership team
Process & Methodology
Agile, SDLC, Roadmap planning
Full 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 Description **Job Summary:** The Senior Manager of Regulatory Affairs, Digitalization is responsible for establishing, executing, and maintaining the central regulatory affairs strategy for digital tools and systems required for regulatory activities and work across BUs and Regions, specifically the Regulatory Information Management System (RIM and/or RIMSYS). This role is accountable for supporting a comprehensive digital regulatory roadmap and portfolio that accelerates innovation, enhances operational excellence, and enables data-driven decision-making across business units and regions. The role has responsibilities for the management, maintenance, and improvements of digital platforms operated and utilized by Regulatory Affairs, including systems related to Regulatory Documentation and Submission Management, and Regulatory Information Management. The Senior Manager of Regulatory Affairs, Digitalization will work with SMEs and stakeholders from Central, BU and Regional teams to ensure user needs are identified and met. Coordinates with cross-functional teams and departments to incorporate global regulatory strategy into GPDS (digital solution). Supports BU digital center of excellence. Through exceptional communication, cross-functional collaboration, and agile problem-solving, the Senior Manager partners with the Senior RA Director, Digitalization, and senior leadership to refine the Regulatory Affairs vision, identify transformative opportunities, and lead high-impact initiatives that elevate BD’s quality s
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