Consultant Medical Product Excellence

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

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

Your Contact Person(s)