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Quality Manager for Medical Devices
2 weeks ago
Welcome to Radiobotics ApS:
We are a dynamic and innovative company that aims to solve the global need for radiologists while ensuring every patient receives expert-level care.
Our vision is to make routine X-rays of the musculoskeletal system augmented and first-line reported by our products, enabling non-specialists to read radiology images assisted by our products.
We are seeking an experienced Quality Assurance/Regulatory Affairs Specialist to join our Clinical and Regulatory team.
In this role, you will be responsible for ensuring the quality and regulatory compliance of our medical devices, developing and implementing QMS procedures, and leading risk analysis for new products.
Your Key Responsibilities:
- Collaborate with cross-functional teams to drive product release projects
- Support design control activities across departments
- Lead risk analysis for new products with support from clinical and development teams
- Review and revise QMS procedures for efficiency and effectiveness
- Assist management in prioritizing regulatory approval activities based on strategy and market potential
- Create and coordinate product submissions for developed devices
- Train the company in QMS procedures
- Participate in internal and external audits
What We Offer:
- A dynamic and innovative work environment
- An opportunity to work on challenging projects
- A competitive salary and benefits package
- The chance to grow and develop your career