€30,000 - €40,000 yearly
Ostoform Limited
Hybrid
Role Purpose
This is an opportunity to play a central role in keeping Ostoform’s quality, R&D and regulatory documentation accurate, complete and ready when it is needed. As Quality & R&D Documentation Coordinator, you will prepare, review, coordinate and maintain quality-system and regulatory documentation throughout the medical-device product lifecycle. You will administer and track documentation supporting product realisation, change control, complaint handling and controlled regulatory updates in accordance with ISO 13485, applicable regulatory requirements and company procedures.
Working closely with Quality, Regulatory, R&D, Operations and Supply Chain, you will help ensure that documentation is accurate, complete, traceable, approved and available within required timelines. You will also coordinate and support the creation of documentation for management assessments and approvals, giving you visibility across a growing medical-device business and its...