Principal Regulatory Affairs Specialist - eRIM Process Lead

Additional Location(s): US-MA-Marlborough; Costa Rica-Heredia; Ireland-Cork; Ireland-Galway; US-MN-Arden Hills\n\nDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\n\nAt Boston Scientific, we\u2019ll give you the opportunity to harness all that\u2019s 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\u2019ll help you in advancing your skills and career. Here, you\u2019ll be supported in progressing \u2013 whatever your ambitions. \n\nAbout the role:\n\nBoston 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.\n\nThe Principal Regulatory Affairs Specialist \u2013 eRIM Process Lead supports the expansion of features in Boston Scientific\u2019s 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.\n\nAs 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.\n\nWork model, sponsorship, relocation:\n\nAt 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.\n\nYour responsibilities will include:\n\nProcess development and ownership\n\n\u25cf 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.\n\n\u25cf 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.\n\n\u25cf Define clear process flows, business rules and decision points that align with regulatory requirements and system capabilities.\n\n\u25cf Coordinate process-related activities with the eRIM Process Support Specialist and other core and extended team members to ensure aligned execution\n\nSystem and requirements collaboration\n\n\u25cf Partner with the Product Owner to translate regulatory process needs into clear system requirements, user stories and acceptance criteria.\n\n\u25cf 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.\n\n\u25cf Act as a key business liaison to ensure regulatory processes are accurately reflected in system configuration.\n\nDocumentation and work instructions\n\n\u25cf 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.\n\n\u25cf Ensure documentation is clear, concise and suitable for a global regulatory audience and external auditing bodies.\n\nStakeholder engagement and communication\n\n\u25cf Engage global and regional Regulatory Affairs stakeholders to gather input, understand current-state practices and assess the impact of new processes.\n\n\u25cf Evaluate diverse feedback, incorporate value-added input and clearly communicate decisions and rationale.\n\n\u25cf Clearly articulate process expectations, roles and responsibilities across functions and regions.\n\nChange enablement and adoption\n\n\u25cf Support change management activities by providing strong process context and rationale for change.\n\n\u25cf Partner with training and change leads to support effective rollout, adoption and continuous improvement of eRIM processes.\n\n\u25cf Serve as champion for the strategic advantages of an enterprise-wide RIM system.\n\nRequired qualifications:\n\n\u25cf Bachelor\u2019s degree in life sciences, engineering, pharmacy, public health, communications or a related discipline.\n\n\u25cf Minimum of 7 years\u0027 experience in Regulatory Affairs or related compliance experience within the medical device industry.\n\n\u25cf Demonstrated working knowledge of FDA, EU or international regulatory frameworks impacting medical device authorization and maintenance.\n\n\u25cf Proficiency with Microsoft Office applications, including Word, Excel and PowerPoint.\n\nPreferred qualifications:\n\n\u25cf Strong written and verbal communication skills, including the ability to translate complex regulatory requirements into clear, actionable guidance, with demonstrated writing, editing, critical-thinking skills and attention to detail.\n\n\u25cf Experience with electronic Regulatory Information Management (eRIM) systems, such as Rimsys, Veeva or Honeywell.\n\n\u25cf Familiarity with Boston Scientific Regulatory Affairs processes and organizational context.\n\n\u25cf Demonstrated ability to influence without authority and collaborate effectively within cross-functional teams.\n\n\u25cf Experience supporting large-scale system or process transformation programs.\n\n\u25cf Experience working in global regulatory environments with regional and country-specific requirements.\n\n\u25cf Strong organizational skills with an audit-ready mindset and documentation discipline.\n\n\u25cf Learning agility and a continuous improvement orientation.\n\n\u25cf Pragmatic problem-solving skills with a coaching mindset.\n\n#LI-Hybrid\n\nRequisition ID: 624200\n\nMinimum Salary: $106800\n\nMaximum Salary: $202900\n\nThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) \u2013 see www.bscbenefitsconnect.com\u2014will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.\n\nCompensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).\n\nCompensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).\n\nFor MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.\n\nAs a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most \u2013 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 \u2013 as a global business and as a global corporate citizen.\n\nSo, choosing a career with Boston Scientific (NYSE: BSX) isn\u2019t just business, it\u2019s personal. And if you\u2019re 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!\n\nAt 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. \n\nBoston 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 identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.\n\nPlease 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\u2019s policies or protocols change with regard to COVID-19 vaccination.\n