And this is what you will bring:
• You have a technical or scientific degree (BSc, MSc or PhD) in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology or similar.
• Minimum 7 to 10 years working experience in the field of medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA), in either manufacturing, R&D, quality or regulatory roles.
• Knowledge of Medical Device Regulations (CE, FDA, PAL, TGA, etc.) and/or quality assurance. Preferably European CE mark on high-risk non-active device and/or clinical experience.
• Pragmatic, enjoying a mix of activities in technology, business processes, regulatory affairs, quality assurance or clinical affairs.
• Communicative and service oriented, supporting a wide variety of clients from small start-ups to large multi-nationals, able to adapt to different company cultures and situations.
• Strong organizational skills, detailed oriented to deal with various projects at the same time.
• Fluent in English.