Principal Regulatory Affairs Specialist

Additional Location(s): US-TX-Austin\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\n \n\nAbout the role:\n\nJoin our Interventional Cardiology team; our products improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions.\n\n \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\n \n\nThe Principal Regulatory Affairs Specialist is responsible for planning, managing and implementing regulatory submissions to the U.S. Food and Drug Administration (FDA), EU notified bodies and worldwide product registrations. This role supports both new product development and ongoing compliance for a broad ablation portfolio, collaborating with cross-functional teams and international regulatory partners to ensure alignment and success.\n\n \n\nWork model, sponsorship:\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.\n\n \n\nYour responsibilities will include:\n\n\u25cf Collaborate on development of sterilization approaches for cardiovascular devices, ensuring alignment with applicable standards, including ISO 11135, ISO 11137, ISO 11737 and ISO 11607, while supporting validation, submissions and lifecycle changes.\n\n\u25cf Lead regulatory assessment of sterilization process changes, ensuring continued compliance with global requirements and integration with biocompatibility and MDR and FDA expectations.\n\n\u25cf Represent the Regulatory Affairs function on cross-functional teams for new product development and sustaining activities, including manufacturing changes, site transfers and continuous improvement projects.\n\n\u25cf Develop U.S. and EU regulatory strategies and prepare submissions for Class II and III medical devices.\n\n\u25cf Create innovative regulatory pathways that support new technologies in collaboration with R\u0026D, Quality, Operations, Medical Safety and Clinical teams.\n\n\u25cf Prepare, coordinate and compile regulatory submissions, including IDEs, 510(k)s, EU MDR technical documentation and pre-submissions.\n\n\u25cf Partner with international regulatory teams to support outside the United States (OUS) registrations and post-market activities.\n\n\u25cf Evaluate product and manufacturing changes for regulatory impact and ensure timely, compliant updates to filings.\n\n\u25cf Lead interactions with the U.S. FDA and EU notified bodies to secure regulatory clearance and approval while ensuring alignment throughout the review process.\n\n\u25cf Provide timely product and project information to global regulatory teams and communicate international requirements to project stakeholders.\n\n\u25cf Foster effective relationships with regulatory agencies by delivering clear, strategic communications and follow-up.\n\n\u25cf Apply strong project management and technical writing skills to drive regulatory deliverables across multiple initiatives.\n\n \n\nQualifications:\n\n \n\nRequired qualifications:\n\n\u25cf Bachelor\u2019s degree in a relevant scientific or engineering discipline.\n\n\u25cf Minimum of 7 years\u0027 experience in Regulatory Affairs, or minimum of 5 years\u0027 experience with an advanced degree in a related discipline.\n\n\u25cf Demonstrated leadership in regulatory strategy, project planning and cross-functional execution.\n\n\u25cf Experience interpreting global regulatory requirements to ensure alignment with cost, schedule and performance goals.\n\n\u25cf Proven ability to influence and negotiate with global regulatory authorities.\n\n\u25cf Proficiency with U.S. and EU medical device regulations, including quality system standards and clinical investigation requirements.\n\n\u25cf Strong understanding of the product lifecycle, including development, clinical studies, manufacturing and change control.\n\n\u25cf Hands-on experience preparing IDEs, 510(k)s and EU MDR submissions.\n\n\u25cf Excellent analytical, technical writing and communication skills.\n\n\u25cf Proficiency in Microsoft Word, Excel, PowerPoint and Adobe Acrobat.\n\n \n\nPreferred qualifications:\n\n\u25cf Direct experience submitting regulatory filings to the FDA, EU MDR and other global agencies.\n\n\u25cf Deep knowledge of FDA regulations, EU MDR, MDCG guidance, ISO 13485, ISO 14971 and related global standards.\n\n\u25cf Ability to work independently and mentor junior regulatory staff.\n\n\u25cf Experience serving as the primary regulatory contact for the FDA and/or notified bodies.\n\n\u25cf Proven ability to manage multiple projects and priorities effectively.\n\n\u25cf Strong problem-solving mindset with a focus on quality, results and timely delivery.\n\n \n\nRequisition ID: 628985\n\nMinimum Salary: $97000\n\nMaximum Salary: $184300\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\nBoston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.\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