Senior Business Process Analyst

at  Collins McNicholas

Sector: Supply Chain & Logistics
Contact Email: chloe.somers@collinsmcnicholas.ie
Job Ref: 22770
Due to expansion, our client a Medical Device leader in Galway is looking for a Senior Business Process Analyst with Regulatory Project Control experience for a global transformation program. This is a Permanent, Hybrid position.

REQUIREMENTS

• 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.
• Experience of managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization.
• 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.

As a Senior Business Process Analyst, you will be responsible for the following:

• 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 Workstreams, Strategic Integration Vendors, 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 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.