Drive regulatory strategy and registration across global markets for a defined group of ConvaTec products, driving regulatory processes and activities
Job Summary
Drive regulatory strategy and registration across global markets for a defined group of ConvaTec products, driving regulatory processes and activities.
Prepare and submit regulatory dossiers (US FDA 510(k) submissions; EU CE Marking and UKCA Technical Documentation), and interface with authorities during the review process.
Foster thorough knowledge of regulatory principles and compliance with regulatory policies throughout the organization through training and mentorship.
Matching Summary
Drive regulatory strategy and registration across global markets for a defined group of ConvaTec products, driving regulatory processes and activities.
Skills & Requirements
Must-have
Global regulatory strategy
Regulatory submissions
Product life cycle management
Medical device regulations
QMS compliance
Nice-to-have
Training and mentorship
Process improvement projects
Industry committee participation
Key Requirements
2+ years relevant experience
Life Science Degree or equivalent experience
Experience with FDA CFR 820
Experience with EU MDR 2017/745
Experience with Notified Bodies/Competent Authorities/US FDA