Principal Regulatory Affairs Specialist

About the role Join our Interventional Oncology and Embolization team, where we create the next generation of cryoablation systems designed to treat abnormal tissue. Our products improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions. The 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. Work model, sponsorship Hybrid work model requiring employees to be in our local office in Maple Grove, Minnesota, 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. Responsibilities 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. Develop U.S. and EU regulatory strategies and prepare submissions for Class II medical devices. Create innovative regulatory pathways that support new technologies in collaboration with R&D, Quality, Operations, Medical Safety and Clinical teams. Prepare, coordinate and compile regulatory submissions, including IDEs, 510(k)s, EU MDR technical documentation and pre‑submissions. Partner with international regulatory teams to support overseas registrations and post‑market activities. Evaluate product and manufacturing changes for regulatory impact and ensure timely, compliant updates to filings. Lead interactions with the U.S. FDA and EU notified bodies to secure regulatory clearance and approval while ensuring alignment throughout the review process. Provide timely product and project information to global regulatory teams and communicate international requirements to project stakeholders. Foster effective relationships with regulatory agencies by delivering clear, strategic communications and follow‑up. Apply strong project management and technical writing skills to drive regulatory deliverables across multiple initiatives. Qualifications Required qualifications Bachelor’s degree in a relevant scientific or engineering discipline. Minimum of 7 years’ experience in Regulatory Affairs, or minimum of 5 years’ experience with an advanced degree in a related discipline. Demonstrated leadership in regulatory strategy, project planning and cross‑functional execution. Experience interpreting global regulatory requirements to ensure alignment with cost, schedule and performance goals. Proven ability to influence and negotiate with global regulatory authorities. Proficiency with U.S. and EU medical device regulations, including quality system standards and clinical investigation requirements. Strong understanding of the product lifecycle, including development, clinical studies, manufacturing and change control. Hands‑on experience preparing IDEs, 510(k)s and EU MDR submissions. Excellent analytical, technical writing and communication skills. Proficiency in Microsoft Word, Excel, PowerPoint and Adobe Acrobat. Preferred qualifications Direct experience submitting regulatory filings to FDA, EU MDR and other global agencies. Deep knowledge of FDA regulations, EU MDR, MDCG guidance, ISO 13485, ISO 14971 and related global standards. Ability to work independently and mentor junior regulatory staff. Experience serving as the primary regulatory contact for the FDA and/or notified bodies. Proven ability to manage multiple projects and priorities effectively. Strong problem‑solving mindset with a focus on quality, results and timely delivery. Compensation Minimum Salary: $102,100; Maximum Salary: $194,000 (not including variable compensation and bonuses). Salary will be commensurate with experience and responsibilities. Benefits Compensation for non‑exempt (hourly), non‑sales roles may include variable compensation such as overtime and annual bonus target. Exempt, non‑sales roles may include variable compensation, i.e., annual bonus target and long‑term incentives. Equal Opportunity Statement Boston Scientific Corporation is an equal opportunity employer. The Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation and all other personnel decisions are made 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. COVID‑19 Vaccination Requirement Certain U.S. based positions, including 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 for which they have applied requires proof of vaccination. 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. #J-18808-Ljbffr B Capital