QUALIFICATIONS: • BS/BA, Master from a four-year college or university, preferably in a life science field of study • +5 years’ experience in CE submissions for new medical devices and design changes on existing MDs (implants, IOLs, non-active, class I to class III) • In-depth knowledge of MDD 93/42/EEC, global regulations, standards, and guidance documents • Good understanding of general change impacts • Logic thinking and understanding of authorities mindset/expectations • Business sense, strategic thinking • Very well organized and structured • team member during development projects • Ability to write easy to understand STED and other registration documents, rationales; well designed and organized, professionally presented. • requires superb attention to detail • Communicative with other departments, RA/CA team members cross-site and authorities • MS Office software • Project management skills In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together. Join us today. Inspire people tomorrow. Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity. | 
