Senior Business Process Analyst, Regulatory Product Control

Job Title:              Senior Business Process Analyst, Regulatory Product Control (Magellan Project)

Closing Date:       30th April 2024

Work Mode:          Hybrid

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 Senior Business Process Analyst with Regulatory Project Control experience.

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

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.
• 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.

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.