Clinical Lifecycle Manager (m/f/d) - 21h/W (Medical Assistant)

Other job titles: Degree in Natural Sciences; Engineering

Job Description: Do you want to accompany the clinical safety and performance of innovative medical devices throughout their entire product lifecycle? In this position, you will coordinate Post-Market Clinical Follow-up (PMCF) and clinical evaluation activities and ensure regulatory compliance in accordance with EU-MDR and MDCG guidelines. In doing so, you will develop strategies for generating and evaluating clinical data and work closely with Clinical Affairs, Regulatory Affairs, Research & Development, as well as other international stakeholders.

Key areas: Clinical Lifecycle Management | PMCF | Clinical Evaluation | EU-MDR | MDCG | Medical Devices | Post-Market Surveillance | Clinical Studies | Regulatory Affairs | Clinical Affairs | Biostatistics | Magnetic Resonance Imaging

Your Tasks

• Planning and coordination of PMCF and clinical evaluation activities across the entire medical device portfolio in accordance with EU-MDR
• Assessment of additional clinical data requirements after market launch as well as development of strategies for the generation, analysis, and use of PMCF data
• Creation and maintenance of PMCF plans and PMCF reports based on Post-Market Surveillance data, clinical trials, and scientific literature
• Support in the creation of clinical evaluation documentation and integration of data from preclinical, non-clinical, and clinical investigations
• Support in the planning and implementation of PMCF activities to confirm and further develop clinical claims
• Cross-functional coordination with Clinical Affairs, Regulatory Affairs, Product Management, R&D, Marketing, as well as external partners and Medical Writers

Your Qualifications

• Completed degree in Medicine, Natural Sciences, Engineering, or a comparable field
• Many years of relevant professional experience as well as sound knowledge of regulatory requirements for clinical activities, especially EU-MDR and MDCG guidelines; knowledge of regulations in the USA and China is an advantage
• Practical experience in Clinical Lifecycle Management, clinical evaluation, and the design of regulatory-compliant processes for medical devices
• Basic knowledge of clinical research, especially study design, Biostatistics, and information management; experience with magnetic resonance technology is an advantage
• Strong communication, presentation, and stakeholder management skills for collaboration in an international and interdisciplinary environment
• Business fluent English skills; German skills are an advantage