Project Leader, Implantable Sensors

The Project Leader will lead a team working on an implantable device. This individual will be responsible for overseeing and directing verification testing and clinical studies from prototype phase through regulatory approval. Specifically, the PL designs study protocols, implements, monitors and completes clinical and non-clinical (analytical) trials for new product releases, regulatory filings, product modifications/claim extensions, and /or new markers in a timely manner and in accordance with regulatory requirements. The PL will work closely as a contact with clinical sites and investigators and represents Clinical Trials and Monitoring on this team; advising the team on the types of testing that will be required based on guidance documents or testing performed for related approved products. The PL works closely with Regulatory Affairs, Research and Development and Project Management to review and to prepare and implement the clinical trial strategy. Master’s degree M.A./M.S in a health-related field with 5 years of healthcare experience or equivalent; or Bachelor’s degree B.S. in a health-related field with 8-10 years of healthcare experience or equivalent. Knowledge of in vitro diagnostics clinical trial processes and regulatory requirements are a strong plus.

Email resume to: hr@novabio.com

Mail resume to: Human Resources

Nova Biomedical

200 Prospect St

Waltham MA 02454

Fax resume to: 781-899-6259

Please visit our website at www.novabiomedical.com for more information.