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Principal Specialist, Product Owner - Global Regulatory Affairs Operations

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote in Country
Onsite Location(s): 

Arden Hills, MN, US, 55112

Additional Location(s): US-MN-Arden Hills; US-IN-Spencer; US-MA-Marlborough; US-MN-Maple Grove; US-MN-Minnetonka

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.


Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.


About the role: 


The Regulatory Affairs information management system is intended to be a global business transformation for our Regulatory Affairs teams and cross functional partners. This Regulatory Affairs information management system will be a set of processes and IT capabilities used to manage documents and data related to regulatory activities throughout the lifecycle of a product. The system is intended to improve Global Regulatory Data Quality and Management and enable projects which will simplify, standardize and modernize our business processes, enabling BSC to better leverage the power of data and to position our business for profitable and sustainable growth.
As the Product Owner, you will play a key role in ensuring the successful realization and adoption of this new system across BSC quality systems. This role will operate in a Scaled Agile Framework, reporting to the Director of Global Regulatory Affairs Operations. Their main duties include determining the overall vision of products, managing various backlog items and deciding which features each product will have according to clients’ preferences.
This role represents the Regulatory Affairs function, collaborating with the Information Technology, Selected Vendor, SME, COP teams and Stakeholders across the network. 


Your responsibilities include:

•    Coordinating with Information Technology, Strategic Integration Vendors, SME’s, Communities of Practice’s, and Stakeholders across the network to develop a strong and deep pool of expertise across Regulatory processes and Applications.
•    Aligning Requirements, monitoring project plans, communicating with Stakeholders, coordinating the Requirements, Design, Build and Testing Phases and supporting the world-wide deployment of the Regulatory Affairs information management system. 
•    Working closely with the IT team to construct requirements, design, test, and approve system releases within an agile style release cycle.  Write and shepherd User Stories through the intake process.
•    Participating in Scrum meetings and product sprints
•    Gaining alignment on system capabilities and inputs/attributes.
•    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.
•    Conducting working sessions to identify what product data model attributes will be available in each system. Determine what information must be received/communicated with each system.
•    Developing and editing existing user stories
•    Reaching alignment on baseline/assumed product model for MaRS
•    Liaising with the Training team and Change Management Specialist to develop training plans 
•    Communication to Steering Committee, Quality System Governance Board, Core Team, Regulatory Community and other Stakeholders
•    Managing RADs board with oversite over additional regulatory IT or IT adjacent projects (Python, BOTs, Excel, SQL databases) to ensure cohesiveness in approach, assessment of need for incorporation into overall project, and aid in cost/benefit analysis
•    Sustaining product owner and administrator/trainer for RegIS database using in Agile Khanban methodology; participating in the managing of product backlog and prioritizing them based on changing requirements
•    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 years of work experience
•    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
•    Minimum of years’ experience in Systems/Applications as Product Owner or SME
•    Previous experience with a major Program introduction/upgrade, ideally within an IT/Systems or Business representative role.
•    Experience with 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 GSM, Remedy, and JIRA
•    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.
•    Ability to establish, communicate and engage teams in the vision & strategy of the program
•    Ability to create 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)




Requisition ID: 539908


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 is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a drug-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.

Nearest Major Market: Minneapolis

Job Segment: Regulatory Affairs, Compliance, Pharmaceutical, Recruiting, Data Modeler, Legal, Science, Human Resources, Data

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