Consultant Medical Product Excellence

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 th...