Job Summary
An innovative products company is in need of a Remote Regulatory Operations Specialist in Orlando.
Candidates will be responsible for the following:
- Providing regulatory compliance guidance to drive global initiatives such as EU MDR
- Developing and maintaining technical documentation (technical files) required for regulatory compliance
- Participating in cross-functional meetings to provide regulatory perspective and interpretative knowledge
Must meet the following requirements for consideration:
- May require 5% travel annually with possibly some international
- An individual with a regulatory discipline as related to medical device products
- 5+ years of experience writing and assembling technical documentation files or design dossiers
- 3+ years of experience in international and US FDA 510(k) regulatory submissions
- Deep knowledge about new EU MDR and differences to MDD
- All other requirements necessary for this position