| 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
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