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Senior Business Process Analyst - Regulatory Control

  • Sector: IT
  • Contact Email: christopher.otoole@collinsmcnicholas.ie
  • Job Ref: 22613

Due to continued expansion of our clients operations, we are seeking applications from a suitably qualified and experienced Senior Business Process Analysts with Regulatory Project Control experience.

Job Purpose

Our client is running a global business transformation program accompanying a move of their ERP system from SAP ECC to S4 HANA. This programs goal is to simplify, standardise and modernise their core business processes, enabling our client to better leverage the power of data and to position their business for profitable and sustainable growth.

As a Senior Business Process Analyst, you will play a key role in ensuring the successful Business Transformation across our client's working process relating to regulatory product controls. This is a key role, reporting to Snr Manager Product Owner- Product Controls, collaborating with the Workstreams, Process Owners, Community of Practices and Stakeholders across the network.

This role represents the Regulatory business Users, collaborating with the programs Workstreams, Strategic Integration Vendors, COP teams and Stakeholders across the network. The Program will have the following phases: Requirements Gathering, Design, Build and Testing, Deployment to post Go Live sustaining.

Responsibilities

  • 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,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 organisational and personal objectives

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

  • 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 organisation by empowering others, rewarding and celebrating superior performance, and creating an inclusive workplace across eight locations

  • Experience of managing complex matrixed organisational structures and demonstrated capability in collaborating and influencing across such an organisation

  • 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.

For more information on this role and a confidential discussion please contact Chris O Toole

christopher.otoole@collinsmcnicholas.ie

091 706713