Regulatory Affairs Specialist II

Regulatory Affairs Specialist IIWork mode: Hybrid Onsite Location(s): Marlborough, MA, US, 01752 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: At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work. 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. In the Urology division, we continually advance the quality of patient care with innovative urology solutions. We have a robust product portfolio and pipeline and continue to invest in urology treatments. This role is responsible for Regulatory Affairs support for submissions and ongoing regulatory compliance throughout the product development process. The role will also develop regulatory strategies and provide support for new business development efforts involving external manufacturers, including original equipment manufacturers (OEMs) and contract manufacturers. The position requires strong U.S., EU, China and international regulatory experience that can be leveraged to support international expansion. The ideal candidate will demonstrate flexibility in their work schedule to accommodate business needs and collaboration across teams.Work model, sponsorship, relocation: At 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.Your responsibilities will include:Provide technical guidance and regulatory training and mentoring to Regulatory Affairs employees and cross-functional teams.Assist with developing and implementing regulatory strategies for new and modified medical devices, as well as OEM and contract manufacturer partnerships.Serve as a liaison for new business partners, providing regulatory guidance for U.S., EU, China and international product registrations.Act as a core member of manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.Prepare and submit global regulatory applications and maintain internal regulatory file documentation.Review and approve product and manufacturing changes for compliance with applicable regulations.Support and maintain quality initiatives in accordance with Boston Scientific's Quality Policy.Continuously assess opportunities to improve quality.Develop and implement departmental and divisional policies and procedures.Support highly technical or major business-segment product lines, special projects and strategic initiatives.Review device labeling and advertising materials for compliance with global regulations and analyze and recommend appropriate changes.Qualifications: Required qualifications:Bachelor's degree in a scientific, technical or related discipline.Minimum of 2 years' Regulatory Affairs experience in the medical device industry.Experience with 510(k) submissions, EU MDR and international regulatory registrations.Working knowledge of FDA, EU and international regulations for medical devices.Ability to read and interpret global regulations and standards.General understanding of the product development process, design controls and quality system regulations.General understanding of regulations applicable to the conduct of clinical trials.Preferred qualifications:Experience supporting both capital equipment or medical electrical equipment and single-use disposable medical devices.Experience supporting contract-manufactured and/or OEM products.Ability to manage multiple projects simultaneously.Proficiency with Microsoft Office.Effective research and analytical skills.Effective written and oral communication, technical writing and editing skills.Ability to work independently with minimal supervision.The anticipated compensation listed above will 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.Boston 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.Boston 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.