International Regulatory Affairs [Austria]
Medical Devices class III - MDR – combination devices Join the Headquarter of an impressive independent Medical Devices company in Switzerland! Innovative implants registered as class II-III medical devices are developed, manufactured and distributed on site. Some of the exciting products are drug-device combination products! $ads={1} Your Challenges Implement the new MDR in the regulatory processes with MDD considering for class II – III medical devices Prepare international submissions Develop and write clear arguments and explanations for new product certifications and license renewals Monitor and set timelines for certification and/or license variations and renewal approvals Provide input to project teams during the development of regulatory plans & filing strategy to ensure acceptable labelling in markets assigned Provide regulatory intelligence information to the organization Your Experience BSc/MSc degree in scientific discipline biology, ...