Clinical Evaluation Manager (100%)As one of the world´s 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: Bülach | Working hours: Full-time | Type of contract: UnlimitedApply now under: www.biotronik.com/careersJob ID: 61312 | Martina Micciulla | Tel. +41 75 429 56 23
