Description
The regulatory submissions that you will work on are mostly for the FDA, but there will be many international submissions as well. The group is full product life cycle, and so it does all pre-market submissions and post market changes. You will report to the director of regulatory affairs. The division creates blood-screening in-vitro diagnostics. The pay is upward of $140,000, and you may have several direct reports.The team is looking for a candidate who is:
- A very strong communicator
- Passionate about the technology and submissions
- Outgoing and likeable
- Very well educated
- Experienced in PMA or IDE submissions
- Familiar with in-vitro diagnostics
Minimum qualifications
- 5 years of regulatory affairs experience in the medical device or diagnostics industry
- BS degree, preferably in science or engineering
- PMA or IDE experience is preferred
- 510(K) clearance experience
- International submissions experience is preferred
To find out more about Real please visit www.realstaffing.com