Senior Business Process Analyst, Regulatory Product Control
Boston Scientific
- Galway
- Permanent
- Full-time
- The role represents the Regulatory and Product Control Business Users in the Agile ERP team, working closely with Stakeholders to translate User Requirements into Quality 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 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.
- Supporting a cross functional network to deliver the Magellan Transformation for regulatory product controls.
- Aligning Requirements, monitoring project plans, communicating with Stakeholders, coordinating the Requirements, Design, Build and Testing Phase and supporting the network-wide Deployment.
- Fostering an inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational and personal objectives
- Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Science, Computer Science, Business or related field required.
- 3+ years technical professional or operational experience in medical device field required.
- Strong knowledge of regulatory and product control processes with Boston scientific is preferred
- Previous experience of a major Program introduction/upgrade, ideally within an IT/Systems or Business representative role desired but not essential.
- Working knowledge of ERP, MES and PLM systems and the broader Application Ecosystem (eCERT, CAPA, GCMS, FARS, etc.), and Interfaces, combined with knowledge of key business processes.
- A proven track record of Continuous Improvement, system upgrades/enhancements, proactive problem solving or LBP.
- 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 eight locations
- Experience of managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization
- Good listening and communication skills, with ability to transfer knowledge efficiently.
- Demonstrated high degree of integrity, professionalism, and the ability to establish credibility
- High sense of urgency and commitment to execution.
- Previous experience of Scale Agile Project Management an advantage and/or proven adaptability, comfortable with change and with a demonstrated ability to react and response to a fast-changing environment.
- Role location is flexible, with participation at Team meetings, collaborative project events, with an Ireland/EMEA focus through to 2026 and on site across BSC.