Regulatory Affairs Specialist III

Additional Location(s):US-MN-Maple Grove; Ireland-Galway 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 make an investment in Interventional treatments. This Regulatory Affairs Specialist III role will provide regulatory support on Interventional Cardiology devices with a focus on development and execution of EU MDR recertification activities. Additional activities can include new product introduction, evaluation of post market design changes, international submission support, audit and compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business. This is a hybrid position (in office minimum three days per week) ideally in Maple Grove, MN with the flexibility to be located in Galway, Ireland. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist. Your responsibilities will include: Research, develop, and implement regulatory strategies for medical devices (new or modified) with a focus on EU MDR recertification Develop and implement departmental policies and procedures with an emphasis on compliance activities supporting EU MDR recertification Act as company representative under minimal supervision, developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategy/regulatory pathway development, requirements, and submission review Represent Regulatory Affairs on core teams, providing regulatory feedback and guidance throughout the project or product development cycle Prepare and submit regulatory documentation and applications Review and approve product and manufacturing changes, device labeling, and advertising materials for compliance with regulatory requirements Support and maintain Quality initiatives in accordance with BSC Quality Policy Continuously assess ways to improve Quality Required qualifications: A minimum of a bachelor's degree in a scientific, technical, or related discipline At least 3 years of experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D, Biocompatibility) within the medical device industry, with a minimum of 2 years specifically in a Regulatory Affairs role Prior experience with EU MDR regulation and submissions Preferred qualifications: Working knowledge of FDA, EU, and international regulations for medical devices Ability to manage several projects of moderate scope and complexity simultaneously while adhering to time schedules Effective research, analytical, and problem-solving skills Excellent written and oral communication, technical writing, and editing skills. Ability to translate technical information into a clearly written message for regulators Basic submission, communication, and presentation related computer skills, including experience with software applications such as Microsoft Word, Excel, Teams, and PowerPoint and Adobe Acrobat Quick learner, self-motivated, and independent worker with minimal supervision Works well in fast-paced cross-functional te m environments #LI-Hybrid Requisition ID:593552 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's status, age, mental or physical disability, genetic information or any other protected class. Boston Scientific maintains a prohibited substance freeworkplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. 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