Director, QA/RA

The purpose of this job is to provide Regulatory expertise in Med-CAD. The Computer-aided Diagnosis & Therapy group was launched 4 years ago as an internal venture at the company with worldwide responsibility for bringing CAD solutions to market. This includes cutting-edge research; QSR-compliant product development; upstream and downstream marketing; internal coordination; business strategy; clinical validation; regulatory approvals internationally; etc. The Med-CAD group defines CAD broadly as decision-support systems for clinical diagnosis based on multi-modality imaging data (x-ray, CT, MR, NM, US,..) and clinical data. In support of this new venture, the RA Director , as a member of CAD group’s strategic management, with have full responsibilities for: Regulatory Affairs, participate in the Med-CAD's Strategy team to guide the regulatory strategy for individual projects (510(k)'s to PMA's). In addition, he/she will be responsible for the execution of regulatory strategy; all submissions; working with external interfaces and CAD group’s R&D, and Quality group. . The position requires coordinating efforts among the internal departments within Siemens CAD group (R&D, Quality, Marketing, Legal, Service, etc) and scientific and clinical collaborators to ensure that high quality preclinical and clinical data which will withstand scrutiny from regulatory and scientific bodies are collected in a timely, accurate, cost-effective manner. In doing so, there is also a responsibility to ensure that the rights, health, and safety of study subjects are protected, and that the studies are conducted in accordance with regulatory and industry standards.

CAD group’s products include both Class II and Class III software devices, and the group is responsible for ensuring regulatory compliance worldwide for these innovative and cutting edge products. Since the products in intelligent clinical decision support are novel, the group is breaking new grounds with the FDA in device description and manufacturing concepts. The group already has an original PMA approved and several 510(k) cleared devices. Additional PMA activities are ongoing, along with the challenges of global launches of the group’s products.
REQUIREMENTS
BS degree in engineering or medical/health sciences required BME, RN; additional education (e.g., MS, MD) preferred,. CRA Clinical Research Associate Certification a plus. Minimum of 10 years experience. Excellent interpersonal skills and communication skills (verbal and written) required. Computer proficiency in Microsoft Word, Excel, Access, Powerpoint. Negotiation skills. Knowledge of FDA IDE Regulations, EU Regulations, Good Clinical/Laboratory Practice.

Send your resume in Word format to [Click here for email].