Consultant Medical Product Excellence

Medical Office - Basel, Frankfurt, Kosice, Boston, Malaysia, Singapore

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Your profile / requirements

• 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. 
• Basic knowledge of clinical validation and evidence generation 
• Strong analytical skills with the ability to structure and analyse 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  
• Fluent in English 
• 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 

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