Quality Management System Expert
3 days ago
Are you passionate about quality and regulatory affairs in the medical device industry? Do you have a strong background in quality management systems and regulatory requirements? We are seeking a talented QA/RA specialist to join our Clinical and Regulatory team at Radiobotics and contribute to our mission of solving the global need for radiologists while ensuring every patient receives expert-level care.
The successful candidate will be responsible for maintaining superior product quality, driving our strategy for placing products on new markets, and collaborating with our clinical and development teams. You will be engaged in all stages of product development, from design control to product submissions, and will work closely with our cross-functional teams to ensure compliance with regulatory requirements and industry standards.
Main Responsibilities:
- Maintain superior product quality and drive our strategy for placing products on new markets
- Collaborate with our clinical and development teams to ensure compliance with regulatory requirements and industry standards
- Engage in all stages of product development, from design control to product submissions
- Work closely with our cross-functional teams to ensure seamless and efficient submission processes
- Ensure compliance with regulatory requirements and industry standards through regular audits and reviews
Requirements:
- At least 1 year experience within quality assurance and/or regulatory affairs, and knowledge that working with quality and regulatory processes within the medical device field is the right path
- Positive can-do attitude with a thorough and structured mindset
- Excellent communication skills in English and experience with working within or leading cross-functional projects
- Knowledge of quality management systems and regulatory requirements within MDR and ISO 13485, and ideally 21 CFR
- Experience with Software as a Medical Device
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