Regulatory Affairs Specialist
Magenta are looking for an experienced RA Specialist to join one of our Medical Device clients due to an expansion within the company. The purpose of this role is to ensure that procedures for complaint handling, adverse event reporting and post market surveillance are in accordance with applicable regulatory requirements.
- Maintain awareness of changes in regulatory requirements and associated guidance relevant to Products and markets and report to the Quality Manager for presentation at management review
- Support the day to day operation of the Quality Management System as required
- Conduct all activities in accordance with Healthcare Compliance and Bribery Act regulations
- Prepare regulatory submission for new and existing products for global markets
- Provide advice and guidance to the new product development process.
- Experience in the medical device industry in a Quality or regulatory capacity
- Auditing experience
- Previous experience of Q-Pulse