Job description and responsibilities
File Reviews: Perform assessment of manufacturer’s clinical evaluation reports and corresponding documents of medical devices (e.g. Hip Implants) and active implantable medical devices (e.g. ICD Devices). Draw up records and reports demonstrating the result of the relevant conformity assessment activities. Review and scientifically challenge the clinical relevant pre-clinical and clinical data contained within the clinical evaluation, and any associated clinical investigations and make a recommendation to the notified body’s decision maker
Project Management: Project management potentially consists of selling clinical services, issuing quotes, coordinating multiple projects and answering client and colleagues’ questions.
Customer Service: Communicate in a courteous and effective manner with internal and external customers in all circumstances including answering questions, relaying messages, and providing information regarding standards, regulatory and technical requirements for compliance with standards and the respective regulatory system.
Expertise: Keep abreast of present and pending regulatory requirements, standards and TÜV SÜD service capabilities through internal training sessions, external seminars, and reading of scientific articles
University degree as physician, medical degree or medical doctor
Minimum four years in health care services or related sectors including; orthopedic surgery
Minimum of two years: In usage, development or testing/evaluation of orthopedic medical devices or in clinical study or clinical evaluation of such devices
Highly proficient in spoken and written English. German language knowledge is a plus.
Excellent organizational and communication skills
Computer Skills: MS Office (Word, Excel, Powerpoint, Outlook)
Project Management Skills: Task management, prioritization, delegation, task separation, scheduling
Occasional international travels up to 20% are required.