Key skills
Communication
About this role
Role Overview
- Manage 30+ rebranding CMPs for EMEA MedSurg Business (Solventum plants & vendors)
- Support with process improvement and make it faster while remaining compliant
- Support of redline creation of artworks and do the approvals of incoming rebranded artworks
- Prepare and update technical documentation for Class I, IIa, IIb, and III medical devices in compliance with EU MDR and ISO 13485.
- Reg Desk to support SOS RAs (setting up trackings for EU and DCTs)
Requirements
- Bachelor’s Degree
- Fluent written and verbal English skills
- Good understanding of regulatory processes of medical devices
- Good knowledge in corporate quality management systems
- Knowledge in technical documentation for Class I, IIa, IIb, and III medical devices in compliance with EU MDR and ISO 13485
- Good communication skills, ability to escalate open topics and follow up on completion
- Project coordination and problem-solving in dynamic environments.
Benefits
- Many programs to help you live your best life – both physically and financially.
- Competitive pay and benefits, regularly benchmarks with other companies that are comparable in size and scope.
- Diversity & Inclusion as an equal opportunity employer.