Regulatory Affairs Specialist II

 Additional Location(s):  N/A 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, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Interventional Cardiology (IC), we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. We have a robust product line and pipeline, and we will continue to invest in Interventional treatments.  This Regulatory Affairs Specialist II role will provide regulatory support across a broad portfolio of Interventional Cardiology devices, with a primary focus on U.S. and EU compliance activities. Responsibilities include support for U.S. Annual Reports, EU MDR PSUR and SSCP annual reviews, EU MDR recertification activities, audit support, and general compliance initiatives. The role may also include support for new product introductions, evaluation of post-market design changes, and process optimization efforts—aligned with global medical device regulations and broader business objectives. This is a hybrid position based in Maple Grove, MN (in office at least three days per week).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:● Represent Regulatory Affairs on core teams, providing regulatory feedback and guidance throughout the project or product development cycle● Act as a company representative, developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategies, regulatory pathway development, and full submission review processes● Prepare and submit regulatory documentation and applications focused on compliance requirements● Review and approve product and manufacturing changes, device labeling, and advertising materials for regulatory compliance● Support and maintain quality initiatives in accordance with Boston Scientific’s Quality Policy● Participate in the development and implementation of departmental policies and procedures● Continuously assess ways to improve quality and compliance practices● Provide internal and external audit preparation and support● Support innovation within Regulatory Affairs by proposing process optimization and efficiency strategiesQualifications: Required qualifications:● Minimum of a bachelor’s degree in a scientific, technical, or related discipline● Minimum of 2 years' experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industry, including at least 1 year in a Regulatory Affairs role● Introductory knowledge of FDA and EU regulations for medical devices● Basic computer skills, including proficiency in Microsoft Word, Excel, Teams, PowerPoint, and Adobe Acrobat Preferred qualifications:● Working knowledge of FDA, EU, and international regulations for medical devices● Ability to manage multiple projects of moderate scope and complexity simultaneously while meeting deadlines● Effective research, analytical, and problem-solving skills● Excellent written and oral communication, technical writing, and editing skills; ability to translate technical information into clearly written regulatory messaging● Advanced computer skills to support submission preparation and internal/external communication (e.g., MS Word linkages, section formatting, table of contents creation)● Self-motivated, quick learner who can work independently with minimal supervision● Comfortable working in fast-paced, cross-functional team environments #LI-Hybrid  Requisition ID: 618595Minimum Salary: $69500 Maximum Salary: $132000  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 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.