Bd
Medical Technology
RegulatoryAffairsSpecialist,Digitalization
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Regulatory Affairs Specialist, Digitalization at Bd. Skills: Digital Regulatory System, Regulatory Documentation, Submission Management, IT Systems. Support Global RA Digital Platforms. Support the Digital RA Portfolio”
What You'll Achieve.
Accelerates innovation; Enhances operational excellence; Enables data-driven decision-making; Timely delivery; Measurable outcomes; Stakeholder alignment; Achieve measurable outcomes
Industry & Context.
Problem Solving; Analytical Skills; Professional Judgement; Decision Quality; Dealing with Ambiguity
What They're Looking For.
Must Have
Bachelor's degree in science, engineering, or technology, Minimum 3 years in Medical Device industry, Minimum 5 years working with IT to launch and maintain systems following GxP, Computer Systems Validation (CSV) and Software Development Lifecycle (SDLC) standards
Nice to Have
Master's degree in business, management, or technology related field, Minimum 3 years in Medical Device industry, with roles in Regulatory Affairs and/or Quality Systems
What You'll Do.
Support Global RA Digital Platforms
Support the Digital RA Portfolio
Form Cross-Functional Partnerships
Help Define and Align Key Driver Goals
Support RA System Optimization
Leverage digital tools and automation
How You'll Work.
Team & Collaboration
Cross-functional teams; Central, BU and Regional teams; SMEs and stakeholders; Cross-functional teams and departments; Central teams, business units and regional partners
Communication Scope
Exceptional communication; Skilled facilitator
Process & Methodology
Agile problem-solving
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 Regulatory Affairs Specialist, Digitalization is responsible for executing and maintaining the central regulatory affairs activities and work across BUs and Regions, specifically for the RIMSYS system. This role is accountable for supporting a comprehensive digital regulatory system 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 the RIM and/or RIMSYS digital platforms operated and utilized by Regulatory Affairs related to Regulatory Documentation and Submission Management. The Regulatory Affairs Specialist, 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 RA Specialist partners with the Senior RA Manager, Digitalization and senior leadership to refine the Regulatory Affairs vision, identify transformative opportunities, and lead high-impact initiatives that elevate BD’s quality standards and customer trust. **Job Responsibilities:**_(Primary Duties, Roles, and/or Authorities)_ **_Primary Responsibilities_****:** * **Support Global RA Digital Platforms** : Supports
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