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Senior Clinical Evaluator Medical Devices (f/m/x)

Berlin
Vollzeit
15.08.2023

locationsBerlinJenaOberkochenLa RochelleFull timeposted onPosted 30+ Days Agojob requisition idJR_1025825Carl Zeiss Meditec AG enables medical professionals worldwide to improve the lives of their patients in ophthalmology, microsurgery and other medical growth sectors. With our proven medical technology and application expertise, we are driving standards of care. Together with our colleagues in locations around the world, we work every day to achieve this goal.Strategy development of clinical options and documents for new intraocular lenses with relevant interfaces (R&D, Marketing, Quality, SSC, etc.)Identification and analysis of clinical regulatory requirements relevant for approvals as well as derivation of clinical strategies for international registration in main marketsCollaboration with clinical research department on clinical trial strategy (CDP). Definition of appropriate design of pre- or post-approval clinical trials sponsored by Carl Zeiss MeditecAssessment of risks as well as timelines, economic factors and definition of appropriate mitigation measuresParticipation in product risk analysis and benefit risk determination for new or already registered productsParticipation in global cross-location projects for new registrations, approval of product changes or changed requirements triggered by legislative changesCreation and writing of the set of clinical documents required for registration and maintenance of medical devices including CEP, CER, PMCF plan and report, PMS plan and report, State of the Art, SSCPYour Profileminimum 5 years of experience in Clinical Affairs/Clinical evaluation in the medical device industry or with contract research organizationsgood knowledge of relevant regulatory requirements for clinical trials for medical devices (ICH-GCP, ISO 14155)in-depth expertise of relevant regulatory requirements in clinical evaluations for medical devices (MDR, MDCG, MEDDEV)understanding of ISO 11979 series and ISO TR 22979 and / or of Chinese and US-FDA regulation for intraocular lenses would be a plusability to act independently while effectively collaborating within a team environmentYour ZEISS Recruiting Team:

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Veröffentlicht am 15.08.2023