Regulatory Affairs Fellow - ERP Functional Lead

Additional Location(s): US-MA-Marlborough; Costa Rica-Heredia; Ireland-Galway

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.                

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 hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills, MN, Marlborough, MA, Heredia, Costa Rica or Galway, Ireland.  You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
  
 
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

 
 
Required Qualifications:
 

• Minimum of a bachelor’s degree or equivalent work experience
• Minimum of 7 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
• 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

 
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
• 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
• Willingness to travel to divisions, regions, and corporate headquarters (estimate 15% travel in non-pandemic conditions)

Requisition ID: 590914

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.