Senior Regulatory Affairs Specialist

Additional Location(s):  US-MA-Marlborough; US-MN-Maple Grove   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.          About the role: 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.   At Boston Scientific, our Urology business provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. These conditions account for more than 50% of all urology surgical procedures.   As a Senior Regulatory Affairs Specialist , you will provide Regulatory Affairs support for product development, sustaining engineering projects and acquisition integration activities. In this role, you will develop regulatory strategies, prepare global regulatory submissions and partner with cross-functional teams to help ensure products meet regulatory requirements throughout the product lifecycle. This is an exciting opportunity to contribute to innovative technologies while supporting strategic initiatives that help expand Boston Scientific's Urology portfolio.   Work model, sponsorship: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in their local office at least three days per week. The position may be based in Maple Grove, Minnesota, or Marlborough, Massachusetts . Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.   Your responsibilities will include: ● Provide technical guidance and regulatory training and mentoring to Regulatory Affairs team members and cross-functional partners. ● Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy, regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. ● Develop and implement regulatory strategies for new and modified products. ● Act as the Regulatory Affairs lead on product integration workstreams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle while coordinating team inputs for regulatory submissions. ● Review and approve design and manufacturing changes, ensuring compliance with applicable regulations. ● Prepare and submit global regulatory applications, including U.S. and EU MDR submissions, maintain internal regulatory documentation and support international regulatory submissions. ● Review device labeling and advertising materials for compliance with global regulations, analyze findings and recommend appropriate changes. ● Provide training on departmental and divisional policies and procedures. ● Support highly technical product lines, including product integrations, sterilization processes and other special projects or strategic initiatives. ● Participate actively in regulatory collaborations and alignment with other regulatory specialists supporting product integration efforts. ● Foster a work environment of continuous improvement that supports Boston Scientific's Quality Policy, Quality System and applicable regulations for the area of responsibility.   Qualifications:   Required