Principal Regulatory Affairs Specialist

Recruiter: Spencer Gregory Hale

Principal Regulatory Affairs Specialist  

About the role:  

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, standardize and modernize 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 Regulatory Affairs Functional Lead, you will play a key role in ensuring the successful Business Transformation across the worldwide BSC Regulatory organization and the realization and adoption of this new system into BSC quality systems. Reporting to the Director for the Global Regulatory Affairs Operations team, this role represents the Regulatory Affairs users, collaborating with the Magellan Workstreams, Master Data Team, Site Leads and other Stakeholders across the network.  The Program will have the following phases: Requirements Gathering, Design, Build and Testing, Deployment to post Go Live sustaining.

  
This is a position that can be worked hybrid from our Marlborough MA, Maple Grove MN, Arden Hills, MN, or Spencer, IN jobsites.   

Your responsibilities include:

• Leading and managing a functional interaction and engagement with the Magellan Project, typically collaborating with team leads / product owners.
• Aligning on requirements and influencing the Magellan Development Teams to develop solutions/system capabilities and inputs/attributes appropriate for the function in areas of Regulatory Product Controls, Trade Compliance (invoicing, country of origin), Labeling Localization, and more
• Establishing connections with other functions/product owners for their workstream decisions and assessing impact to regulatory functional processes and requirements
• Conducting working sessions to identify system requirements and opportunities for enhancement of system and processes.
• Coordinating with Magellan Product Owners, Master Data Team, Process Owners, Division and Country Regulatory as well as SMEs, Communities of Practices, and Stakeholders across the network to develop a strong and deep pool of expertise across Regulatory processes and Applications.
• Communicating with Regulatory community and Stakeholders through creation of functional specific communications as well as cascading communication from the Magellan Project.
• Supporting Regulatory process and system updates to react to the inputs / outputs of the ERP system and enable process optimization that maybe enabled with new functionality.
• Identifying and surfacing risks/questions.
• Participating in site, product and functional meetings to stay on top of what is happening that may impact the Regulatory Function as well as represent the Regulatory Function.
• Proactively influencing global site 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 Regulatory and Quality Business processes and Applications.
• Providing input into the development of training materials and plans. 
• Creating an environment that encourages constructive feedback and coaching and proactive developmental support for all employees.
• Fostering an inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational and personal objectives.

Minimum Qualifications:

• Minimum of a Bachelor’s degree with a minimum of 5 years’ experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, IVD, pharmaceutical or healthcare industries (or a minimum or 8 years regulatory work experience within med device if no degree).
• Strong knowledge of regulatory and product control processes
• Previous experience of a major Program introduction/upgrade, ideally within an IT/Systems or Business representative role.
• 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.

Preferred Qualifications:

• Experience with SAP (GTS) and JIRA
• Working knowledge of MES and PLM systems and the broader Application Ecosystem (eCERT, CAPA, GCMS, FARS, etc.) and Interfaces, combined with knowledge of key business processes.
• Ability to establish, communicate and engage teams in the vision & strategy of the program
• 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 multiple locations.
• 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.
• High sense of urgency and commitment to execution.
• Willingness to travel to divisions, regions, and corporate headquarters (estimate 15% travel in non-pandemic conditions).
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 Requisition ID: 583083

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.