Job Summary
A technology company is in need of a Remote Regulatory Manager in Bethesda.
Individual must be able to fulfill the following responsibilities:
- Compile data related to investigational device & drug safety & compliance in order to prepare & manage regulatory reports & submissions
- Assist with the preparation and completion of FDA Investigational Device Exemption (IDE) applications for novel treatments
- Assist with the preparation and completion of FDA Investigational New Drug (IND) applications for novel medications
Position Requirements Include:
- Bachelor’s in Biology, Biomedical Engineering, Bioengineering, Nursing or health-related field
- Experience in clinical research data management including analysis, data query management & audits for cardiovascular device studies
- Expertise with Good Clinical Practice regulations & procedures, with ability to implement in design or management of device research
- Experience interacting with regulatory bodies relevant to sponsorship of novel clinical device studies including FDA, IRBs, DSMBs, etc
