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Principal Business Process Analyst

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 23114

Due to expansion, our client a Medical Device leader in Galway is looking for a Principal Business Process Analyst for a global transformation program. This is a Permanent, Hybrid position.


The Role:

As the Principal Business Process Analyst Regulatory Product Controls, you will play a key role in ensuring the successful Business Transformation across the business. This is a key role, reporting to Snr Manager Product Owner- Quality and Regulatory Controls, collaborating with Workstreams, Process Owners, Community of Practices and Stakeholders across the regulatory network.


Responsibilities

  • 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 Workstreams, Strategic Integration Vendors, , 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 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.

Requirements

  • 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 Program and how that relates to the Regulatory strategy.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717