Principal Business Process Analyst

Job Title: Magellan Principal Business Process Analyst, Regulatory Product Controls

Job Title:               Magellan Principal Business Process Analyst, Regulatory Product Controls

Closing Date:       30th April 2024

More than the opportunity of a lifetime......the opportunity to improve lives 

For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine.  The Company's products help physicians and other medical professionals improve their patients' quality of life by providing alternatives to surgery.  Since 1994, employees in Galway have been at the forefront of some of these truly innovative medical device designs and manufacturing. 

Due to continued expansion of our operations, we are seeking applications from a suitably qualified and experienced Principal Business Process Analyst Regulatory Product Controls.

Job Purpose

Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S4 HANA. Magellan’s goal is to simplify, standardise and modernise our core business processes, enabling BSC to better leverage the power of data and to position our business for profitable and sustainable growth.

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

This role represents the Regulatory business Users, collaborating with the Magellan 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 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.

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 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.
   

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. If you require any arrangements during the recruitment process, please let us know.