Fellow, Regulatory Affairs

Boston Scientific•Georgetown, MA

2d•$131,700 - $250,200•Hybrid

About The Position

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: Regulatory Subject Matter Expert (SME) on multiple products, technologies and regions. Devotes a significant portion of time to leadership at both the franchise level and functional level, including department employee development responsibilities. Work Mode: At Boston Scientific, we value collaboration and synergy. This role has a hybrid or remote work model and will require travel to associated meetings and project-related events. This role follows a remote work model.

Requirements

Minimum on 8 years of experience with a BA degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines.

Responsibilities

Provides regulatory expertise with respect to global commercialization strategy development, execution and risk management
Participates in advocacy/outreach with Sr. franchise and functional leaders to achieve Urology business objectives and assess commercialization pathway trade-offs
Provides regulatory expertise to facilitate entry into new therapeutic areas, technologies and design; and new regulated regions such as emerging markets
Drives clarity into product approval and post market requirements through effective problem identification, communication and use of regulatory agency network
Operates effectively as regulatory team lead on assigned projects including global regulatory strategy development and execution
Assesses and manages global dependencies and opportunities to coordinate regulatory efforts serving as liaison to both regional BSC RA personnel and Agencies, and internal functional and program management stakeholders
Capable of authoring and executing / supporting all aspects of Global Regulatory Strategies
Supports New Business Development by performing regulatory due diligence on candidate companies and products/programs; provides initial regulatory project management for integration of new companies and products into the Urology divisional structure; acts as RA Core Team Member PDP programs
Leads regulatory-related education efforts and mentoring in areas of expertise
Studies and understand applicability of relevant regulations to the business
Researches competitive product regulatory approvals and pathways, and disseminates to relevant stakeholders
Supports Quality System and audit readiness through maintenance and provision of regulatory information to QA, Notified Bodies and FDA