Boston Scientific Principal Business Process Analyst 

Ireland, Galway 

319956788

Reporting to:Snr Manager, Product Owner Regulatory Product Controls

Closing Date:13th May 2024

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

2. You meet the educational requirements for the role

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.

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.