Consultant Medical Product Excellence

Darum lohnt es sich

Basic knowledge of clinical validation and evidence generation Strong analytical skills with the ability to structure and analyze data Ability to support problem-solving within defined scope Developing structured and systematic thinking Strong communication and collaboration skills Ability to prepare structured documentation and presentations Ability to work effectively in cross-functional and interdisciplinary teams Ability to manage tasks and deadlines with guidance Willingness to learn, seek feedback, and continuously develop skills Ability to adapt to new tools, technologies, and regulatory environments Tasks and Responsibilities Contribute to project deliverables and support project leads in Medical Product Excellence engagements Execute work packages with guidance across product lifecycle management, regulatory readiness, and validation activities Support product lifecycle and regulatory readiness assessments Assist in evidence-generation planning, documentation, and analysis Contribute to clinical validation activities and technical research Apply analytical skills to solve structured problems within defined scope Ensure quality and compliance with regulatory and organisational standards Perform routine tasks independently with guidance for more complex activities Support project-related client interactions and communication Build understanding of client needs and regulatory environments Apply foundational knowledge in product lifecycle, regulatory, and clinical domains Follow established processes, methodologies, and tools Support development of templates and tools for clinical, regulatory, and product-related deliverables Contribute to internal knowledge management and documentation of project learnings Provide feedback on methodologies, tools, and ways of working Identify minor process inefficiencies and suggest improvements Support project extensions and renewals through high-quality delivery Contribute to proposal development and preparation of sales materials Provide input based on research, analysis, and project experience Develop a professional voice and presence within the organisation Maintain a professional personal brand as a subject matter expert in development within Medical Products Contribute to internal publications, opinion pieces, and thought leadership content #J-18808-Ljbffr Medical Office - Basel, Frankfurt, Kosice, Boston, Malaysia, Singapore Qualifications Master’s or Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field MD or PhD preferred for technical areas 3–5 years (with a Master’s/Bachelor’s degree)/1–3 years (with an MD or PhD) of experience in MedTech, regulatory affairs, clinical development, or related areas Initial exposure to product lifecycle or regulatory projects is a must Understanding of product lifecycle management and regulatory fundamentals Working knowledge of medical–regulatory interface and compliance requirements Familiarity with FDA and/or EU MDR regulations is preferred Foundational understanding of medical device requirements engineering, medical risk analysis, and/or usability engineering.