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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! 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
- 3 years of experience in general regulatory affairs
- Experience with international medical device (class II & III) regulatory approvals and submissions
- In depth knowledge on the new MDR and/or international regulations
- Strong project management