Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for the preparation, creation, regular updating, and submission of documents to acquire and maintain worldwide approvals, e.g. CE, 510 (k), PMA, etc.Monitoring, maintaining, and reporting regulatory status
• Contact - also review function - for all interfaces (R&D, PM, FoB, MarCom, RA SSC, RA dealers, etc.) in the assigned area of responsibility as well as for competent authorities and external partners
• Identification of relevant documents for the registration and communication to related areas such as R&D, FoBs
• Preparation of decision and recommendation for product registration including independent preparation of approval strategies (Regulatory Clinical Strategy Plan RCSP)
• Management of / or cooperation with global cross-site projects for new registrations and approval of product changes or changes in legal requirements
• Management of / or cooperation to optimize site-wide RA processes
• Performing training courses for interfaces and contact persons. If necessary, also create necessary training documents
• Potential: participate and support audits
• Local RA budget overview and planning
• 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.
Internal Number: 34450
Carl Zeiss Meditec Production, LLC is located in the city of Ontario in California, about 40 miles (64 km) east of Los Angeles. Founded in 1989 as Oii, later Aaren Scientific, the company was an early innovator in computer-controlled intraocular lenses (IOL) production, and was the first U.S. IOL manufacturer to be awarded CE registration.
The company has been integrated into ZEISS Medical Technology Business Group, and complements the existing ZEISS IOL development and manufacturing sites.