Minimum 5 years medical device regulatory experience
Experience with local regulatory submissions
Knowledge of quality management systems
This role involves developing regulatory strategies and managing compliance activities for a global medical products company focused on chronic conditions
Job Summary
This role involves developing regulatory strategies and managing compliance activities for a global medical products company focused on chronic conditions.
The successful candidate will interact with local health authorities to ensure timely regulatory approval and manage product lifecycle maintenance including license renewals.
Convatec offers flexible working arrangements, ongoing learning opportunities, and competitive remuneration as part of their commitment to employee wellbeing.
Matching Summary
This role involves developing regulatory strategies and managing compliance activities for a global medical products company focused on chronic conditions.
Salary
Not specified; Competitive remuneration offered
Skills & Requirements
Must-have
Minimum 5 years medical device regulatory experience
Experience with local regulatory submissions
Knowledge of Quality Management Systems
Ability to manage product lifecycle maintenance
Review and manage regulatory documentation procedures
Nice-to-have
Regulatory Affairs Certification (RAC) preferred
Experience in Good Distribution Practice for Medical Devices
Familiarity with ISO13485 standards
Support for reimbursement and tender applications
Collaboration with supply chain and marketing teams
Key Requirements
Bachelor's or Master's degree in science or Medical Technology
Minimum 5 years of experience in medical device regulatory affairs
Regulatory Affairs Certification (RAC) is preferred but not mandatory