Specialist I, Regulatory Affairs
Enable Injections Inc.•Sharonville, OH
•Onsite
About The Position
This is a full-time, onsite position for a Specialist I in Regulatory Affairs. The role involves supporting cross-functional teams and regulatory submissions, assisting the Regulatory Lead, conducting research, writing technical summaries, and preparing various regulatory documents for both US and global markets. The position also includes responsibilities related to finished product artwork and labels, post-market surveillance, and documentation for clinical studies.
Requirements
- Bachelor’s in biology, chemistry, engineering, or related science field
- Strong interpersonal skills
- Technical/scientific writing experience
- Proficiency in PowerPoint and Microsoft Office
- Strong initiative and eagerness to learn
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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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
