Medical Office - Basel, Frankfurt, Kosice, Boston, Malaysia, Singapore
- Master’s or Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field
- MD or PhD preferred for technical areas
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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
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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
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Foundational understanding of medical device requirements engineering, medical risk analysis, and/or usability engineering.
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Basic knowledge of clinical validation and evidence generation
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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
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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
- 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
