Job Description

Clinical Evaluation Manager (100%)





As one of the worlds leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.






The Medical Affairs Group is responsible for the design, conduction and evaluation of international first-in-man, regulatory submission and post-marketing trials.

Your Responsibilities

Develop, revise, and review clinical documents--including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) plans and reports, Summaries of Safety and Clinical Performance (SSCPs), and Clinical Investigator Brochures (CIBs)--and ensure their quality, accuracy, and timely completion for submission to regulatory authorities and notified bodies Perform literature searches/reviews to ensure up-to-date knowledge, support document development, and provide subject matter expertise across departments Support risk management activities, including the development and maintenance of product risk analyses and benefit-risk assessments Act as a core team member in product development projects Communicate clinical evidence and regulatory rationale clearly to internal stakeholders and external partners Contribute to continuous improvement of templates, processes, and best practices in clinical evaluation and medical writing Collaborate closely with risk management, R&D, regulatory affairs, study managers, biostatisticians and marketing

Your Profile

MD or PhD ideally in life sciences, medicine, or a related field (cardiovascular experience strongly preferred) 2-5 years of experience in medical writing preferably within the medical device or pharmaceutical industry, including authorship of clinical study reports, protocols, and peer-reviewed publications Excellent presentation and moderation skills, including technical editing and quality control skills Good understanding of statistics, with the ability to interpret complex clinical data Team-oriented, accurate and self-dependent personality with an analytical working style and exceptional attention to detail Knowledge of MEDDEV 2.7/1 rev. 4 and MDR Experience with ISO 14971 and FMEAs, as well as knowledge in Risk Management are a plus Excellent command of spoken and written English, proficiency in German is highly desirable Strong organizational and time-management skills, with the ability to prioritize multiple projects in a fast-paced environment Proficiency with literature databases (e.g., PubMed) and reference management tools (e.g., EndNote, Citavi); experience with systematic review tools is a plus Experience with or strong interest in AI-based tools for literature review and clinical evaluation, and willingness to contribute to their evaluation and continuous improvement



Are you interested?




Please apply online via our application management system. We are looking forward to welcoming you!




Location: Bulach | Working hours: Full-time | Type of contract: Unlimited




Job ID: 61312 | Martina Micciulla | Tel. +41 75 429 56 23