My client is in the process of expanding their regulatory team and is looking to bring a senior specialist aboard!
This company is a global healthcare leader with a portfolio of technologies that spans the spectrum of healthcare, with products in diagnostics, medical devices, nutritional, and branded generic medicines. Additionally, they have a great benefits package as well. As a medical device company, they are looking for someone with strong IVD and device experience. The company growth shows no signs of stopping, so now is the time to apply and see what they're all about.
In this role you will be responsible for:
- Providing regulatory guidance for project teams
- Prepare U.S. regulatory submissions (PMA and 510(k))
- Support the creation of EU documentation
- Perform regulatory assessments
- Ensure compliance with FDA
The client requires that all candidates have:
- Bachelor's degree or higher
- 4+ years' experience in regulatory devices
- Medical device experience
- IVD and 510K experience
- Strong communication skills