Title:  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