Our client is a very small company with a unique product that a government agency is funding to begin prototype manufacturing because the agency wants the product for our warriors. It will allow the company to commercialize their business without having to raise the funds required to make that happen. They will also obtain FDA approval for their device. Your risk of joining this company is greatly reduced. Funding should occur in the 2nd or 3rd week of June.
- Develop and manage a detailed plan for a drug-device combination project, from a prototype
stage to FDA approval via a 505(b)(2)
- Manage 3 internal engineering teams, developing the device and manufacturing process and
- Support CMC Leader’s drug development, drug-device integration, GMP manufacturing, and
- Support regulatory leader and regulatory consultants
BSME, BSBiomedE, BSChemE with 15 years of experience in new product development project
Strongly prefer experience with a start-up or rapidly growing early stage or small company.
Knowledge of and experience with ISO13485 and especially design controls.