Reg Affairs Specialist II

1 month ago

Minneapolis, United States Boston Scientific Gruppe Full time

You’ll discover a place where you can have meaningful purpose, improving lives through your life's work. 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 Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure, and protecting against sudden cardiac arrest. In addition, we offer solutions with 3D Mapping and Navigation systems, Radiofrequency Ablation catheters, Diagnostic Catheters, EP recording systems, and Intracardiac Access Sheaths. Boston Scientific develops, manufactures, and markets a broad array of products and services that enable less-invasive care for some of the most threatening cardiac conditions. We’ve been expanding indications and conducting pivotal research for nearly 20 years, resulting in increased access to the lifesaving and life-enhancing benefits of ICD and CRT therapies. About the role: Under supervision, the Regulatory Affairs Specialist II is responsible for planning, managing, and implementing regulatory approvals to the FDA, notified body and other country specific product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals. Your responsibilities will include: Researches and advises company on country specific international product registration and compliance related requirements. Coordinates, compiles, and submits US and international regulatory filings for new and modified products, including IDEs, PMAs, PMA supplements, IDE periodic reports, PMA annual reports, CE Mark dossiers and updates, and other country specific product registrations. Reviews test protocols and reports for inclusion in regulatory filings. Assesses labeling, advertising, and promotional materials for regulatory compliance and support of claims. Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filing. Represents RA on cross functional product development and manufacturing support teams. Works with clinical affairs on various aspects of clinical trials and clinical reports. Required qualifications: Minimum of a bachelor's degree in life sciences, engineering, or related field. Minimum of 3 years regulatory experience. Preferred qualifications: Working knowledge of regulatory requirements for medical devices. Effective written and oral communication and technical writing skills. Basic writing and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat. Experience with Class II or Class III medical devices submissions. Experience with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations. Experience working directly with FDA, notified bodies and/or international health authorities. Strong technical, research, problem-solving, and leadership skills. Ability to communicate complex ideas clearly and simply both orally and in writing. Demonstrated ability to effectively lead multiple projects and priorities. Team player with excellent interpersonal skills. Requisition ID: 586865 Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. #J-18808-Ljbffr

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