Regulatory Affairs Specialist II

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 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 Minimum of 1 year in a Regulatory Affairs role 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