Medical Device Quality Assurance Specialist for Product Registration and Market Development
14 hours ago
At Radiobotics, we are seeking an experienced QA/RA specialist to join our Clinical and Regulatory team. This is a temporary consultancy position to support the company while we search for a permanent hire.
The ideal candidate will have at least 1 year of experience in quality assurance and/or regulatory affairs within the medical device field. They will be responsible for defining and delivering on our strategy to maintain superior product quality and take lead on placing our products on new markets.
As a QA/RA specialist, you will become the expert in all corners of our Quality Management System. You will be engaged in all stages of product development and help define the structure of technical documentation, as well as ensuring our internal quality processes are well-oiled.
You will play a central role in placing products into new markets, maintaining our products in existing markets, and participating in audits from notified bodies and authorities. Your main tasks will include:
- Co-driving product release projects in collaboration with the project manager from the development team
- Supporting other departments in design control
- Leading risk analysis for new products, with support from our clinical and development team
- Reviewing and revising QMS procedures to ensure they are efficient and effective
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