Principal Regulatory Affairs Specialist - eRIM Process Lead

Principal Regulatory Affairs Specialist - eRIM Process Lead

Location:

Marlborough, MA, US, 01752

Additional Locations: US-MA-Marlborough;
Costa Rica-Heredia;
Ireland-Cork;
Ireland-Galway; US-MN-Arden Hills

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 was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

The Principal Regulatory Affairs Specialist – eRIM Process Lead supports the expansion of features in Boston Scientific’s electronic Regulatory Information Management (eRIM) system and the adaptation of processes to integrate the technology. This individual serves as the Process Lead on the business support team and partners closely with the Product Owner, Data Lead, Change Management and Training Lead, and cross-functional Regulatory Affairs stakeholders to ensure global regulatory processes are clearly defined, fit for purpose and scalable across phases of the eRIM program.

This role will report into Global Regulatory Affairs Operations, a corporate/global function.

As part of our continued team growth, we are expanding our team within this function. Please visit the Boston Scientific Careers site to explore related openings and apply to the position that best matches your background.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• Serve as a core business team member for the eRIM program, contributing to the design and implementation of the global RIM solution and operating model.
• Lead the transformation, development, and documentation of end-to-end regulatory business processes aligned with eRIM program phases, including worldwide authorizations and registrations, regulatory submission planning and tracking, submission and correspondence storage, international change notification and response and future-state regulatory processes beyond initial go-live.
• Define clear process flows, business rules and decision points that align with regulatory requirements and system capabilities.
• Coordinate process-related activities with the eRIM Process Support Specialist and other core and extended team members to ensure aligned execution.
• Partner with the Product Owner to translate regulatory process needs into clear system requirements, user stories and acceptance criteria.
• Collaborate with the Data Lead to define regulatory data elements and attributes, support data standards and governance decisions and ensure alignment between processes, data capture and downstream use.
• Act as a key business liaison to ensure regulatory processes are accurately reflected in system configuration.
• Author and maintain high-quality process documentation, including work instructions (WIs), standard operating procedures (SOPs), knowledge sharing documents (KSDs), and other supporting guidance and training-ready materials in collaboration with the Change Management and Training Lead.
• Ensure documentation is clear, concise and suitable for a global regulatory audience and external auditing bodies.
• Engage global and regional Regulatory Affairs stakeholders to gather input, understand current-state practices and assess the impact of new processes.
• Evaluate diverse feedback, incorporate value-added input and clearly communicate decisions and rationale.
• Clearly articulate process expectations, roles and responsibilities across functions and regions.
• Support change…