Job Summary
A technology company that provides a regulated digital health platform to biopharma and medtech companies has an open position for a Remote Senior Quality Assurance Engineer.
Core Responsibilities of this position include:
- Developing and implementing regulatory strategies and overseeing regulatory submissions
- Interfacing with health authorities for digital health software
- Conducting employee regulatory training and providing mentorship on global compliance
Required Skills:
- 5 years experience in a regulated and technical environment in a medical device company
- Experience with successful preparation, submission and clearance/approval of Technical File, Design Dossiers, 510(k), PMA, and international registrations
- Knowledgeable of MDD and MDR, IVDR, ISO13485, IDE and 510(k) premarket notification
- Excellent knowledge of regulations (21CFR), FDA law and CE marking
- Experience preparing for and participating in pre-submission meetings
- Strong working knowledge of FDA regulations, including knowledge of software as a medical device development process
