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Additional Location(s):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 (BSC) is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We are looking for aRegulatory Affairs Specialist I to work in our rapidly growing Coronary Therapies franchise. We are looking for future regulatory leaders to partner with our global R&D and quality teams in our continued journey to evolve technologies and drive future generations of products. We seek a dynamic individual focused on professional development in an innovative environment offering a diverse mix of regulatory opportunities encompassing the full life cycle of cardiovascular devices. If you are interested in a varied and important role and think you will be a good fit, please apply. 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. Relocation is not available at this time for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time. Your responsibilities will include: Assists in 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 in drafting regulatory strategies for new and modified medical devices Assists core team members on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle Assists with preparation and submission of regulatory applications, as well as internal regulatory file documentation Assists with reviewing device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes Assists with reviews and signs-off on product and manufacturing changes for compliance with applicable regulations Required Qualifications: Bachelor's Degree in life sciences, engineering or an equivalent 1+ year of technical or medical device experience(in industry or academics) Basic computer skills, including experience with Microsoft Office, Word, Excel, PowerPoint and Adobe Acrobat Preferred Qualifications: Ability to communicate complex ideas clearly and simply both orally and in writing Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment Team player with excellent interpersonal skills #LI-Hybrid Requisition ID:597596 Minimum Salary: $56500 Maximum Salary: $107300 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--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. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 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 identify, 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. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran