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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