Overview
Join to apply for the Clinical Evaluation Manager (100%) role at BIOTRONIK Vascular Intervention
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
* 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
Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Other
* Industries: Medical Equipment Manufacturing
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