Specialist I, Regulatory Affairs

Location: Onsite Status Type: Full Time QUALIFICATIONS Required: Bachelor’s in biology, chemistry, engineering, or related science field Skills & Competencies: Strong interpersonal skills Technical/scientific writing experience Proficiency in PowerPoint and Microsoft Office Strong initiative and eagerness to learn Physical Requirements: Must be able to remain in a stationary position for extended periods of time Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. Position requires being physically present on the premises during regular company hours or as approved by management RESPONSIBILITIES: Support cross-functional team deliverables and regulatory submissions Assist Regulatory Lead in executing deliverables Perform literature-based research Write technical summaries Assist in preparation of master files, technical files, and other submissions (US and global) Support preparation of finished product artwork and labels Develop knowledge of ISO 13485, 21 CFR 820, 21 CFR Part 4 requirements and domestic/international regulatory framework Support post-market surveillance obligations per applicable US and global requirements (including MDR) Ensure finished product artwork and labels are clear, comprehensible, and user-friendly Assist in preparation of documentation for investigational clinical studies (IND, IDE) in US and globally Support cross-functional team activities as directed