Principal Regulatory Affairs Specialist - eRIM Process Lead (Remote)

About the Role

We are seeking a Principal Regulatory Affairs Specialist - eRIM Process Lead to join our team at Boston Scientific. This role offers the opportunity to work remotely while leading the expansion of features in our electronic Regulatory Information Management (eRIM) system. You will collaborate with cross-functional teams to ensure that global regulatory processes are clearly defined and scalable across all phases of the eRIM program.

What You'll Do

• Serve as a core business team member for the eRIM program, contributing to the design and implementation of the global RIM solution.
• Lead the development and documentation of end-to-end regulatory business processes aligned with eRIM program phases.
• Define clear process flows, business rules, and decision points that align with regulatory requirements.
• Partner with the Product Owner to translate regulatory process needs into clear system requirements.
• Author and maintain high-quality process documentation, including work instructions and standard operating procedures.
• Engage with global and regional Regulatory Affairs stakeholders to gather input and assess the impact of new processes.
• Support change management activities by providing strong process context and rationale for change.
• Act as a champion for the strategic advantages of an enterprise-wide RIM system.

Requirements

• Bachelor’s degree in life sciences, engineering, pharmacy, public health, or a related discipline.
• Minimum of 7 years' experience in Regulatory Affairs or related compliance experience within the medical device industry.
• Demonstrated working knowledge of FDA, EU, or international regulatory frameworks impacting medical device authorization.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Strong written and verbal communication skills, with the ability to translate complex regulatory requirements into clear guidance.

Nice to Have

• Experience with electronic Regulatory Information Management (eRIM) systems, such as Rimsys or Veeva.
• Familiarity with Boston Scientific Regulatory Affairs processes.
• Experience supporting large-scale system or process transformation programs.
• Strong organizational skills with an audit-ready mindset.

What We Offer

• Competitive salary range of $106,800 - $202,900.
• Opportunity to work in a diverse and inclusive environment.
• Access to the latest tools and training to advance your skills and career.
• Support for continuous improvement and professional development.
• Hybrid work model with flexibility to work remotely.