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

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

Reporting to:        Snr Manager, Product Owner Regulatory Product Controls

Closing Date:       13th May 2024

Apply through Success Factors attaching an updated CV. Queries to Jean Mc Morrow (Hiring Manager) or Martina Burke (Talent Acquisition Team)

**IMPORTANT**

Please ensure that you also submit an email to Galway-TalentAcquisition@bsci.com, confirming that:

1. You have informed your Supervisor/Manager of your application

2. You meet the educational requirements for the role

Job Purpose

Key skills and experience: Min 5+ years direct medical device Regulatory Affairs experience with extensive knowledge of regulatory requirements and distribution product control.

As the Principal Regulatory Product Controls Business Process Analyst, 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.

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.

Responsibilities

• The role represents the Global Regulatory Business Users in the Agile ERP team, translating regulatory requirements into regulatory product distribution system controls.
• Proactively influencing Global Regulatory and Quality and divisional regulatory leaders in areas of new concepts and adoption of Best Practice.
• Ensure understanding and translation of strategies, goals, and the full scope of a Business Transformation initiative.
• Simplify and standardize to best practice across Quality and Regulatory Business processes and Applications.
• Building a cross functional network to deliver the Magellan Quality and Regulatory Transformation. 
• Aligning Requirements, monitoring project plans, communicating with Stakeholders, coordinating 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.
• 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.
• Extensive knowledge of Regulatory requirements, working knowledge of SAP and the broader Application Ecosystem.
• Studies and understands applicability of relevant guidance and regulations Internationally and supports regulatory-related education efforts and mentoring in areas of expertise.
• Ability to shape, establish, communicate, and engage teams in the vision & strategy of the Magellan Program and how that relates to the Regulatory strategy.
• Provides leadership and technical guidance in regulatory expertise to coach and support business analysts with less experience.
• Drives execution of program deliverables, solves diverse and complex problems, innovates to improve.
• Collaborates and builds strong relationships and trust with business stakeholders.
• 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.