Consultant Medical Product Excellence, Lucerne

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.

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