Principal Business Process Analyst
Boston Scientific
- Galway
- Permanent
- Full-time
- The role represents the Regulatory Business Users in the Agile ERP team, working closely with Stakeholders to translate User Requirements into Regulatory Controls Business User Stories and the 'Who, What, Why' Acceptance Criteria.
- Coordinating and liaison with the other Magellan Workstreams, Strategic Integration Vendors, BSC BPL's, SME's, Communities of Practice's, IT Solution Architects/COE, Quality/Regulatory Stewards and Stakeholders across the network to develop a strong and deep pool of expertise across Quality processes and Applications.
- Liaise with the Training team and Site Super Users/BPLs/SMEs to develop training plans for each of the key Applications to enhance the knowledge base across the Regulatory organization.
- Building a cross functional network to deliver the Magellan Quality and Regulatory Transformation.
- Aligning Requirements, monitoring project plans, communicating with Stakeholders, coordinating the Requirements, Design, Build and Testing Phase and supporting the network-wide Deployment.
- Proactively influencing global Regulatory and Quality and divisional leaders in areas of new concepts, adoption of Best Practice and working to ensure understanding and translation of strategies, goals and the full scope of a Business Transformation initiative and simplify and standardize to best practice across Quality Business processes and Applications.
- Fostering an inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational and personal objectives.
- Creating a sense of energy, excitement, and personal commitment to the organization by empowering others, rewarding and celebrating superior performance, and creating an inclusive workplace across many locations.
- Bachelor's degree in science, engineering or technical field required.
- 5+ years direct medical device Regulatory Affairs experience with international experience at a divisional or country/regional level.
- Provides leadership and technical guidance through regulatory expertise to mentor business analysts with less experience.
- Studies and understands applicability of relevant guidance and regulations Internationally and supports regulatory-related education efforts and mentoring in areas of expertise.
- Drives execution of program deliverables, solves diverse and complex problems, innovates to improve.
- Collaborates and builds strong relationships and trust with business stakeholders.
- Strong knowledge of and experience with quality processes and respective supporting technology and tools.
- Extensive knowledge of Regulatory processes, working knowledge of SAP and the broader Application Ecosystem.
- Ability to shape, establish, communicate, and engage teams in the vision & strategy of the Magellan Program and how that relates to the Regulatory strategy.
- Creates a sense of energy, excitement, and personal commitment to the organization by empowering others, rewarding and celebrating superior performance, and creating an inclusive workplace across many locations.
- Demonstrated high degree of integrity, professionalism, and the ability to establish credibility
- High sense of urgency and commitment to execution.
- Previous experience of Agile or Scaled Agile methodology, design thinking, and lean rituals will be an advantage but not essential.
- Proven adaptability, comfortable with change and with a demonstrated ability to react and response to a fast-changing environment.