Regulatory Affairs Specialist II

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 make an investment in Interventional treatments. This Regulatory Affairs Specialist II role will provide regulatory support on a wide variety of Interventional Cardiology devices with a focus on supporting sustaining commercial products and US and EU submission activities. This is a hybrid position (in office minimum three days per week) in Maple Grove, MN. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA 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 company representative developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategy / regulatory pathway development, requirements, and full submission review process
• Prepare and submit regulatory documentation and applications focused on compliance requirements
• 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
• Participate in development and implementation of departmental policies and procedures
• Continuously assess ways to improve Quality

Required Qualifications : A minimum of a bachelor's degree in a scientific, technical, or related discipline At least 2 years of experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industry, with a minimum of 1 year specifically in a Regulatory Affairs role Introductory knowledge of FDA and EU regulations for medical devices Basic computer skills, including experience with software applications such as Microsoft Word, Excel, Teams, and PowerPoint and Adobe Acrobat

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 Advanced computer skills to support submissions and communication or presentations both internally and externally (e.g., MS Word troubleshooting such as linkages / references, page numbers, Section building, Table of Contents, etc.) Quick learner, self-motivated, and independent worker with minimal supervision Works well in fast-paced cross-functional team environments

Refer to ID 84988404 when applying