Principal Regulatory Affairs Specialist

Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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.  In the Urology division, we continually advance the quality of patient care with innovative urology solutions. We have a robust product line and pipeline, and we will continue to make an investment in Urology treatments.  This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. The ideal candidate will demonstrate flexibility in their work schedule to accommodate business needs and collaboration across teams Your responsibilities will include: Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Acts 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. Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships. Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and international product registration. Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions. Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes. Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations. Support and maintain Quality initiatives in accordance with BSC Quality Policy. Continuously assess ways to improve Quality. Develops and implements departmental and divisional policies and procedures. Supports highly technical or major business segment product lines, special projects or strategic initiatives. Required qualifications: A minimum of a Bachelor’s degree in a scientific, technical, or related discipline A minimum of 7 years Regulatory Affairs experience in the medical industry Prior experience supporting both capital equipment/medical electrical equipment and single-use disposable medical devices. Prior 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 product development process, design control and quality system regulations. General understanding of regulations applicable to the conduct of clinical trials. Preferred qualifications: Prior experience supporting contract manufactured and/or OEM products. Ability to simultaneously manage several projects. 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. Requisition ID: 633802Minimum Salary: $106800Maximum Salary: $202900The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation 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).Compensation 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).For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.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. Learn more at  and follow us on LinkedIn.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.Please 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’s policies or protocols change with regard to COVID-19 vaccination.