GeNO Careers

 

Senior Mechanical Engineer
GeNO is currently seeking a Senior Mechanical Engineer to To design, implement, and maintain the necessary systems for the manufacturing processes and quality improvement activities. Provide the necessary support to the R&D and Pilot Plant for process and quality activities. The position works under the general direction of the VP of Engineering.
Quality Operations Manager
The Quality Operations Manager provides leadership in the development, implementation, and maintenance of quality systems, procedures, and policies to assure compliance standards for drug-device combination products. This includes but is not limited to compliance with FDA 21 CFR 4, 21 CFR 820, 21 CFR 210 & 211, ISO 13485, ICH Q7, ICH Q10 and other industry standards and guidances as required. In addition, the Quality Operations Manager is responsible for management of 5 work streams within the Quality Assurance organization: Quality Operations, Document Management, Complaint Management, Corrective and Preventative Action (CAPA), and Training.
Senior Regulatory Affairs Associate
Assist RA management in the development of global regulatory strategies for combination products (drug-device). Provide support for preparation of submissions (regulatory agency meeting packages, INDs, CTAs, NDAs, technical dossiers, MAAs, and ODAs). Navigate and interpret regulations and provide regulatory guidance to teams across multiple therapeutic areas.