• 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
• +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
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.
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